FDA Device recall Z-1458-2021
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing an…
- 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 DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing an… 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-1458-2021 |
| 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 DF4 ProMRI, REF 404626, UDI: 04035479142131 - 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 60921514 60921555 60922407 60922410 60922422 60922436 60922438 60922439 60922791 60922792 6092…Serial Number 60921514 60921555 60922407 60922410 60922422 60922436 60922438 60922439 60922791 60922792 60922793 60923703 60923724 60923740 60925141 60925169 60925173 60925178 60925184 60925499 60927059 60927066 60927075 60927476 60927478 60927479 60927481 60927491 60927494 60927499 60928721 60928723 60928725 60928726 60928728 60928730 60928773 60928780 60928852 60930277 60930279 60930281 60930284 60930288 60930294 60930300 60930301 60930304 60930305 60930310 60930313 60930314 60930319 60930326 60931702 60931705 60931709 60931710 60931711 60931712 60931731 60931736 60933207 60933208 60933212 60933213 60933216 60933565 60933568 60933575 60933601 60933602 60933607 60934013 60934015 60934019 60934021 60934030 60934034 60934037 60934038 60934673 60934687 60934709 60935497 60935540 60938587 60938593 60938595 60938600 60938622 60938624 60938629 60938635 60938646 60938653 60939568 60939577 60939 |
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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-1458-2021%22
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