FDA Device recall Z-1454-2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing… 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-1454-2021 |
| 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 INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - 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 60841286 60869296 60870124 60870125 60870127 60870130 60870131 60870132 60870136 60870140 6087…Serial Number 60841286 60869296 60870124 60870125 60870127 60870130 60870131 60870132 60870136 60870140 60870141 60870142 60870143 60873307 60873308 60873309 60873310 60873311 60873314 60873315 60873316 60873317 60873319 60873320 60873321 60873322 60873323 60873324 60873325 60873326 60875170 60875171 60875172 60875173 60875174 60875175 60875176 60875177 60875178 60875179 60878810 60878815 60878816 60878817 60878818 60878819 60878821 60878822 60878823 60878824 60878825 60878826 60878828 60878829 60878830 60878831 60878832 60878833 60878834 60878837 60878838 60880125 60880127 60880128 60880129 60880130 60880131 60880133 60880134 60880135 60880144 60880147 60880148 60880149 60881382 60881383 60881386 60881387 60881388 60881389 60881390 60881393 60881394 60881397 60881398 60881399 60881401 60881403 60881404 60881405 60881619 60881620 60881621 60881622 60881624 60881625 60881627 60881628 60881 |
|---|
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-1454-2021%22
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