FDA Device recall Z-1445-2021
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - 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 Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - 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-1445-2021 |
| 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 DX, DF-1, REF 383594, UDI: 04035479125509 - 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 60703003 60703353 60703354 60703936 60703940 60703948 60704288 60704291 60704298 60704306 6070…Serial Number 60703003 60703353 60703354 60703936 60703940 60703948 60704288 60704291 60704298 60704306 60704307 60704309 60704315 60704503 60704504 60704509 60704510 60704517 60704519 60704522 60704756 60704759 60704763 60704765 60704767 60704768 60704772 60704774 60705316 60705327 60705329 60705330 60705334 60705338 60705340 60705345 60705367 60705368 60705370 60705371 60705642 60705649 60705652 60705666 60705670 60705676 60705707 60705715 60706224 60706232 60706233 60707048 60707052 60707053 60707054 60707060 60707063 60707064 60707065 60707066 60707067 60707070 60707072 60707073 60707074 60707076 60707079 60707085 60707089 60707090 60707091 60707092 60707097 60707098 60707099 60707101 60707105 60707106 60707107 60707109 60707110 60707112 60707960 60707965 60707966 60707967 60707969 60707970 60707972 60707976 60707978 60707980 60707982 60707983 60707984 60707985 60707990 60707993 60707 |
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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-1445-2021%22
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