FDA Device recall Z-1457-2021
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing a…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing a… by Biotronik, citing there is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1457-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-08 |
| Published | 2021-04-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biotronik |
| Distribution | US |
Product
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Reason
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Identifiers
| code_info | Serial Number 60921641 60921645 60921650 60921654 60921661 60921676 60921681 60924487 60924853 60925463 6092…Serial Number 60921641 60921645 60921650 60921654 60921661 60921676 60921681 60924487 60924853 60925463 60925466 60925467 60925469 60925472 60927681 60929676 60929681 60929693 60930725 60930727 60930729 60930730 60931822 60931823 60931827 60931828 60931832 60931843 60931848 60931851 60932793 60932796 60932825 60932833 60932835 60934488 60934503 60935883 60937416 60937431 60937444 60937446 60937448 60937455 60937459 60937461 60937463 60938681 60938682 60940313 60940320 60940326 60940335 60940914 60943117 60944369 60944385 60944388 60944390 60946404 60946430 60948922 60948927 60948928 60949789 60953224 60953232 60955316 60955320 60957532 60957533 60957983 60957986 60965646 60965647 60966818 60966819 60966828 60967662 60967668 60968092 60968093 60968094 60968100 60975060 60975061 60975077 60975096 60977491 60977507 60977560 60978758 60979333 60979341 60984636 60984641 60984642 60984651 60984 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1457-2021%22
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