fda
13 records
FDA Device Recall: Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0500
2025-01-22
Class II — There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
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FDA Recall: ev3 Inc. — Class I
20220316
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and emb | Product: Medtronic TurboHawk Plus Directional A...
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FDA Recall: ev3 Inc. — Class I
20220126
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. | Product: Medtronic HawkOne Directional Atherectomy System, Cat...
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FDA Device Recall: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalo
2022-03-16
Class I — The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
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FDA Device Recall: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-
2022-01-26
Class I — Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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FDA Device Recall: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-
2022-01-26
Class I — Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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FDA Recall: ev3 Inc. — Class II
20201007
Labeling discrepancy for the Rated Burst Pressure (RBP) value. | Product: Pacific Xtreme (PTCA Balloon Dilation Catheter)
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FDA Device Recall: Pacific Xtreme (PTCA Balloon Dilation Catheter)
2020-10-07
Class II — Labeling discrepancy for the Rated Burst Pressure (RBP) value.
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FDA Device Recall: EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene
2016-06-29
Class II — Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex" Self-expanding Peripheral Stent Systems, mo...
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FDA Device Recall: ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Ster
2016-05-04
Class II — Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter b...
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FDA Device Recall: ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx o
2015-01-07
Class II — Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
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FDA Device Recall: ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx o
2015-01-07
Class II — Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922452 & SEPX-8-6-40-135, Lot # 9922795) because of a product labeling error.
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FDA Device Recall: ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: A
2014-04-30
Class II — Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery cathe...
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ny_corps
1 records
NY Corp: EV3 CORP.
2015-10-15
DOMESTIC BUSINESS CORPORATION | County: Kings | Jurisdiction: New York
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