fda
11 records
FDA Recall: St. Jude Medical, Cardiac Rhythm Management Division — Class II
20220810
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Med | Product: Merlin 2 PCS MER37000 programmer Model...
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FDA Recall: St. Jude Medical, Cardiac Rhythm Management Division — Class II
20220810
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted b | Product: Merlin PCS 3650 programmer Model 3330 ...
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FDA Device Recall: Merlin 2 PCS MER37000 programmer Model MER3400 software
2022-08-10
Class II — The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during...
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FDA Device Recall: Merlin PCS 3650 programmer Model 3330 software
2022-08-10
Class II — There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers...
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FDA Device Recall: Merlin.net model MN5000 Software
2022-08-10
Class II — The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during...
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FDA Device Recall: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
2022-04-27
Class II — Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth ...
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FDA Device Recall: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
2022-04-27
Class II — Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth ...
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FDA Device Recall: Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC
2020-03-04
Class II — Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no long...
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FDA Device Recall: Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardi
2020-01-22
Class II — Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
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FDA Device Recall: Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP
2016-01-27
Class I — Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
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FDA Device Recall: Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versio
2015-01-21
Class II — Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Qu...
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