FDA Device recall Z-1447-2021
BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - 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 Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - 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-1447-2021 |
| 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 Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - 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 60724952 60725626 60726518 60726521 60726884 60726900 60727195 60727216 60727250 60727384 6072…Serial Number 60724952 60725626 60726518 60726521 60726884 60726900 60727195 60727216 60727250 60727384 60727392 60727796 60728040 60728052 60728058 60728799 60728800 60728805 60728807 60728822 60728826 60728827 60728828 60728837 60728847 60728858 60728881 60728914 60728920 60728938 60729002 60729005 60729018 60729040 60729048 60729055 60729058 60729079 60729086 60729127 60729789 60729791 60729793 60729797 60729803 60729807 60729808 60729816 60730309 60730311 60730313 60730316 60730319 60730330 60730335 60730357 60731398 60731400 60731414 60731415 60737615 60740183 60740279 60740282 60740528 60740537 60740538 60740539 60740543 60740565 60740566 60740567 60740571 60740573 60740574 60740586 60740687 60740720 60740972 60740977 60740978 60740993 60741021 60741025 60741026 60741049 60741298 60741301 60741317 60741320 60741333 60741343 60741619 60741740 60741747 60741762 60741768 60741771 60741 |
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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-1447-2021%22
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