FDA Device recall Z-1444-2021
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - 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 Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - 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-1444-2021 |
| 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 Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - 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 60757356 60760363 60760397 60761628 60761631 60761650 60761661 60761664 60762689 60762696 6076…Serial Number 60757356 60760363 60760397 60761628 60761631 60761650 60761661 60761664 60762689 60762696 60762706 60762707 60762720 60762723 60762729 60762730 60762915 60764027 60764028 60764030 60764031 60764034 60764037 60764038 60764039 60764041 60764042 60764045 60764047 60764049 60764052 60764054 60764179 60764180 60764181 60764183 60765959 60765960 60765962 60765968 60765969 60765972 60765975 60765978 60765980 60765982 60765983 60765985 60765988 60765989 60765990 60765991 60765993 60765996 60767208 60767210 60767212 60767213 60767214 60767217 60768800 60768806 60769428 60769437 60769448 60769449 60769450 60769452 60773007 60774350 60774360 60774363 60774370 60774413 60775554 60775556 60775557 60775561 60775562 60775563 60775564 60775567 60775569 60775574 60775577 60775578 60775579 60775582 60775587 60775590 60775591 60775592 60775594 60775595 60775597 60775601 60775603 60775875 60775 |
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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-1444-2021%22
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