FDA Device recall Z-1442-2021
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and vent…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and vent… 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-1442-2021 |
| 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 DR-T, DF-4, REF383564, UDI: 04035479125202 - 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 | Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744…Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744595 60744596 60744597 60744598 60744599 60744600 60744602 60744603 60744605 60744606 60744607 60744609 60744610 60744611 60744612 60744613 60744614 60744735 60744736 60744739 60744740 60744741 60744742 60744744 60744746 60744747 60744748 60744749 60744751 60744752 60744753 60745675 60745676 60745678 60745679 60745680 60745681 60745682 60745895 60745896 60745897 60745898 60745899 60745900 60745901 60745902 60745903 60745905 60745906 60745907 60745912 60745913 60745914 60746065 60746066 60746069 60746070 60746071 60746072 60746073 60746075 60746077 60746079 60746082 60746083 60746084 60747525 60747526 60747529 60747530 60747531 60747532 60747533 60747534 60747535 60747536 60747537 60747538 60747539 60747541 60747542 60747543 60747625 60747628 60747629 60747630 60747631 60747632 607476 |
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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-1442-2021%22
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