FDA Device recall Z-1451-2021
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
- 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 DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ven… 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-1451-2021 |
| 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 DF-1, REF 393040, UDI: 04035479129552 - 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 60797220 60797221 60797222 60797223 60797224 60797225 60797226 60797227 60797228 60797230 6079…Serial Number 60797220 60797221 60797222 60797223 60797224 60797225 60797226 60797227 60797228 60797230 60797233 60797234 60797235 60797236 60797238 60797239 60797240 60797244 60797245 60798755 60798756 60798757 60798759 60798762 60798764 60798765 60798767 60798770 60798773 60798774 60798775 60798776 60798777 60798780 60798785 60798786 60798792 60798793 60798794 60800603 60800604 60800605 60800607 60800613 60800615 60800618 60800731 60800733 60800736 60800737 60800738 60800740 60800742 60800743 60800744 60800745 60800746 60800778 60800782 60800784 60800786 60800790 60800798 60800801 60800802 60800804 60803291 60803293 60803296 60803297 60803301 60803313 60803315 60803326 60803329 60803330 60803332 60803335 60803720 60803721 60803728 60803732 60803733 60803734 60803736 60803737 60803738 60803749 60803750 60803751 60803753 60803754 60803755 60803758 60803762 60803764 60803768 60807835 60807 |
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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-1451-2021%22
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