co_sos
1 records
EPA (Environmental Protection Agency)
1 records
epa_echo
1 records
fda
118 records
FDA Device Recall: Battery Charging Station; Model: 0998-00-0802;
2026-03-25
Class III — The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has iden...
View Source
FDA Device Recall: CS300 IABP. Software Version CS300 IABP C.01.
2026-03-11
Class II — The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
View Source
FDA Device Recall: CS100 IABP. Software Version CS100 IABP Q.01.
2026-03-11
Class II — The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
View Source
FDA Recall: Datascope Corp. — Class II
20251217
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. | Product: Cardiosave Rescue. Intra-Aortic Balloon Pump system...
View Source
FDA Device Recall: Cardiosave Rescue
2025-12-24
Class III — The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
View Source
FDA Device Recall: Cardiosave Hybrid
2025-12-24
Class III — The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
View Source
FDA Device Recall: Cardiosave Rescue. Intra-Aortic Balloon Pump system.
2025-12-17
Class II — The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
View Source
FDA Device Recall: Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
2025-12-17
Class II — The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
View Source
FDA Recall: Datascope Corp. — Class I
20241002
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and f | Product: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON...
View Source
FDA Device Recall: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0
2024-11-13
Class II — There is discrepant labeling on the inner and outer packaging of the device.
View Source
FDA Device Recall: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use
2024-10-02
Class I — Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data ...
View Source
FDA Device Recall: CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use
2024-10-02
Class I — Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data ...
View Source
FDA Device Recall: CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use
2024-10-02
Class I — Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical d...
View Source
FDA Recall: Datascope Corp. — Class I
20230906
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not compl | Product: Cardiosave Hybrid Intra-Aortic Balloon...
View Source
FDA Recall: Datascope Corp. — Class I
20230906
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of | Product: Cardiosave Hybrid Intra-Aortic Balloon...
View Source
FDA Recall: Datascope Corp. — Class II
20230802
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. R | Product: LINEAR 7.5Fr.IAB, Intra-Aortic Balloon...
View Source
FDA Recall: Datascope Corp. — Class II
20230802
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. R | Product: SENSATION 7 Fr. IAB, Intra-Aortic Ball...
View Source
FDA Recall: Datascope Corp. — Class II
20230315
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance o | Product: Cardiosave Rescue Intra-Aortic Balloon...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-3
2023-09-06
Class I — Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. I...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-3
2023-09-06
Class I — Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-3
2023-09-06
Class I — Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
View Source
FDA Device Recall: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-7
2023-09-06
Class I — Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. I...
View Source
FDA Device Recall: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-7
2023-09-06
Class I — Users were identifying autofill failure conditions on the devices causing pump stops.
View Source
FDA Device Recall: LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to prov
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide c
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide co
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide
2023-08-02
Class II — During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the fe...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800
2023-07-26
Class I — IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery a...
View Source
FDA Device Recall: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800
2023-07-26
Class I — IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery a...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800
2023-07-26
Class I — An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption o...
View Source
FDA Device Recall: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800
2023-07-26
Class I — An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption o...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-5
2023-06-21
Class III — The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
View Source
FDA Device Recall: MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
2023-05-03
Class II — The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers
2023-03-29
Class II — There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impa...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-3
2023-03-29
Class II — There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impa...
View Source
FDA Device Recall: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-7
2023-03-15
Class II — There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Cons...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D99
2023-03-15
Class II — Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, th...
View Source
FDA Device Recall: Cardiosave Rescue. Model Number: 0998-00-0800-83.
2023-03-15
Class II — Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, th...
View Source
FDA Device Recall: Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-3
2023-03-15
Class I — An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy whi...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-3
2023-03-15
Class II — There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Cons...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-3
2023-01-25
Class I — The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
View Source
FDA Recall: Datascope Corporation — Class II
20221102
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error m | Product: LINEAR 7.5Fr. 40cc IAB with Accessorie...
View Source
FDA Device Recall: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra
2022-11-02
Class II — The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or dela...
View Source
FDA Device Recall: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
2022-09-14
Class II — Certain lots containing undersized dilator.
View Source
FDA Device Recall: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
2022-09-14
Class II — Certain lots containing undersized dilator.
View Source
FDA Recall: Datascope Corp. — Class II
20211006
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is | Product: Cardiosave Hybrid Intra-Aortic Balloon...
View Source
FDA Device Recall: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998
2021-12-22
Class I — Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result...
View Source
FDA Device Recall: Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardios
2021-10-27
Class I — A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries we...
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31,
2021-10-13
Class II — The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31,
2021-10-06
Class II — The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is...
View Source
FDA Device Recall: Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic
2021-05-05
Class III — There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Informatio...
View Source
FDA Recall: Datascope Corporation — Class II
20200902
Potential Endotoxin Contamination | Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-
View Source
FDA Recall: Datascope Corporation — Class II
20200902
Potential Endotoxin Contamination | Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indic
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 06
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) -
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Ja
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-0
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N:
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Jap
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Jap
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Ki
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 068
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Jap
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Ki
2020-09-02
Class II — Potential Endotoxin Contamination
View Source
FDA Device Recall: Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an ac
2020-02-12
Class II — Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
View Source
FDA Device Recall: Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave an
2019-11-13
Class II — One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
View Source
FDA Device Recall: CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascu
2019-07-24
Class I — If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.
View Source
FDA Device Recall: CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascu
2019-07-24
Class I — If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.
View Source
FDA Device Recall: CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascu
2019-07-24
Class I — If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
View Source
FDA Device Recall: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiov
2019-07-24
Class I — Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and d...
View Source
FDA Device Recall: CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascu
2019-07-24
Class I — If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
View Source
FDA Recall: Datascope Corporation — Class II
20180516
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allo | Product: BEQ-TOP 22702 ECC W/HMOD 30000, Catal...
View Source
FDA Recall: Datascope Corporation — Class II
20180516
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allo | Product: BEQ-TOP 22300, Custom Tubing Kit, Cata...
View Source
FDA Recall: Datascope Corporation — Class II
20180516
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allo | Product: BEQ-TOP 27610 ECC PACK 3/8, Custom Tub...
View Source
FDA Recall: Datascope Corporation — Class II
20180516
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allo | Product: BEQ-TOP 22301, Custom Tubing Kit, Cata...
View Source
FDA Recall: Datascope Corporation — Class II
20180425
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section. | Product: Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: Th...
View Source
FDA Device Recall: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Num
2018-06-20
Class II — There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
View Source
FDA Device Recall: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Pa
2018-06-20
Class II — There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
View Source
FDA Device Recall: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Num
2018-06-20
Class II — There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
View Source
FDA Device Recall: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part
2018-06-13
Class III — There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
View Source
FDA Device Recall: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number
2018-06-13
Class III — There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
View Source
FDA Device Recall: BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 22701, Catalog No. 701050790
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
2018-05-16
Class II — The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse...
View Source
FDA Device Recall: Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aorti
2018-04-25
Class II — The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
View Source
FDA Device Recall: Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aorti
2018-04-25
Class II — The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
View Source
FDA Device Recall: Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic ba
2018-04-25
Class II — The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
View Source
FDA Recall: Datascope Corporation — Class II
20170419
A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the cle | Product: Custom Tubing Pack with Bioline Coatin...
View Source
FDA Device Recall: SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STA
2017-05-31
Class II — Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during inte...
View Source
FDA Device Recall: Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number:
2017-04-19
Class II — A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.
View Source
FDA Recall: Datascope Corporation — Class II
20160622
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits. | Product: Small Patient ECC Pack, REF BEQ-TOP 24100, Pr...
View Source
FDA Recall: Datascope Corporation — Class II
20160615
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Intr | Product: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon...
View Source
FDA Device Recall: Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets w
2016-06-22
Class II — Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
View Source
FDA Device Recall: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿
2016-06-15
Class II — It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was er...
View Source
ftc_enforcement
2 records
Getinge AB and Datascope Corp., In the Matter of
2009-03-13
FTC live enforcement action FY2009; matched respondent 'Datascope Corp., In the Matter of'
View Source
Getinge AB / Datascope Corp
2009-01-29
FTC merger enforcement action FY2009 matter 910000; matched respondent 'Datascope Corp'
View Source
ny_corps
1 records
NY Corp: DATASCOPE CORP.
1990-01-04
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.