FDA Device recall Z-1455-2021
BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - 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, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - 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-1455-2021 |
| 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, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - 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 60819315 60819319 60819321 60819324 60819326 60819337 60819609 60819617 60819619 60819625 6081…Serial Number 60819315 60819319 60819321 60819324 60819326 60819337 60819609 60819617 60819619 60819625 60819626 60819637 60819639 60819659 60819677 60819680 60819683 60819684 60820683 60820689 60820691 60820692 60820696 60820698 60820700 60820703 60820706 60820721 60821166 60821204 60823863 60826469 60826472 60826478 60826482 60826489 60826656 60826663 60826708 60826730 60826897 60829520 60829533 60829573 60829578 60829579 60831611 60831613 60831616 60831628 60831629 60831631 60831634 60831636 60831877 60831922 60832196 60833111 60833121 60833124 60833127 60833131 60833132 60833137 60833139 60833142 60833145 60833147 60833158 60833680 60833685 60833693 60833694 60833716 60834154 60834158 60834164 60835646 60837393 60837396 60837420 60838766 60838767 60838770 60838853 60838855 60840023 60840027 60840043 60840047 60840462 60840476 60840478 60840579 60869561 60870362 60870364 60870755 60870 |
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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-1455-2021%22
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