FDA Device recall Z-1460-2021
BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and… 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-1460-2021 |
| 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 INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - 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 60781273 60782345 60782367 60782368 60782370 60782375 60784295 60795401 60795403 60795407 6079…Serial Number 60781273 60782345 60782367 60782368 60782370 60782375 60784295 60795401 60795403 60795407 60795413 60799707 60799709 60799710 60799711 60799712 60799715 60799720 60799721 60799723 60799725 60799726 60799727 60799728 60799729 60799730 60799731 60799732 60799733 60799734 60799737 60799738 60799740 60799742 60799743 60799744 60799746 60799747 60799748 60799750 60799752 60799753 60799754 60799755 60801025 60801026 60801029 60801031 60801032 60801034 60801035 60801036 60801038 60801039 60801041 60801042 60801043 60801044 60808193 60808204 60808205 60808207 60808208 60808210 60809399 60809400 60809402 60809403 60809407 60809408 60809409 60809414 60809415 60810269 60810276 60810278 60810279 60810280 60810281 60810282 60810283 60810284 60810285 60810286 60810287 60810290 60810291 60810293 60810294 60810295 60811776 60811795 60811796 60811797 60811798 60811801 60811803 60811804 60811 |
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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-1460-2021%22
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