FDA Device recall Z-1461-2021
BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - 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, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - 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-1461-2021 |
| 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, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - 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 61009745 61031041 61031948 61035465 61035477 61036566 61037118 61037352 61037354 61037367 6103…Serial Number 61009745 61031041 61031948 61035465 61035477 61036566 61037118 61037352 61037354 61037367 61037371 61037377 61037383 61037384 61037386 61037393 61037940 61037953 61037966 61038664 61038665 61038672 61038679 61038700 61038701 61038705 61038709 61038710 61038711 61038715 61038720 61038722 61038731 61038732 61038905 61038929 61039138 61039376 61039377 61039381 61039384 61039385 61039388 61039393 61040798 61040953 61040966 61040978 61040988 61040992 61041010 61041405 61041407 61041495 61041500 61041509 61041543 61041560 61041569 61041572 61041588 61041590 61041830 61041834 61041852 61041855 61042207 61042208 61042219 61042260 61042267 61042320 61042330 61042343 61042928 61042942 61042944 61042965 61043039 61043075 61043283 61043551 61044057 61044061 61044100 61044246 61044258 61044262 61044279 61044280 61044284 61044285 61044286 61044288 61044305 61044306 61044312 61044318 61044 |
|---|
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-1461-2021%22
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