FDA Device recall Z-1450-2021
BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - 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 ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - 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-1450-2021 |
| 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 ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - 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 60819309 60819312 60819314 60819316 60819317 60819332 60819333 60819614 60819616 60819636 6081…Serial Number 60819309 60819312 60819314 60819316 60819317 60819332 60819333 60819614 60819616 60819636 60819638 60819640 60819642 60819643 60819646 60819649 60819652 60819655 60819667 60819682 60819948 60819949 60819954 60819955 60819957 60819964 60819966 60819967 60820682 60820684 60820687 60820690 60820701 60820702 60820704 60820705 60820708 60820709 60820716 60820717 60820720 60820724 60820725 60820726 60821168 60821170 60821171 60821174 60821183 60821184 60821185 60821191 60821193 60821199 60821206 60821207 60821209 60821212 60822252 60822253 60822255 60822256 60822257 60822259 60822262 60822264 60822267 60822269 60822270 60822273 60822278 60822279 60822281 60822543 60822548 60823564 60823569 60823571 60823575 60823576 60823578 60823580 60823602 60823603 60823605 60823607 60823608 60823611 60823612 60823615 60823616 60823618 60823619 60823623 60823629 60823633 60823636 60823641 60823 |
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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-1450-2021%22
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