FDA Device recall Z-1452-2021
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - 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 ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - 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-1452-2021 |
| 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 ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - 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 60758873 60790507 60790508 60790509 60793100 60793104 60793112 60793113 60793114 60793115 6079…Serial Number 60758873 60790507 60790508 60790509 60793100 60793104 60793112 60793113 60793114 60793115 60793120 60793132 60793151 60793446 60793447 60797807 60797810 60797811 60797813 60797818 60797820 60797824 60797825 60797829 60797832 60797833 60797835 60797838 60797840 60797841 60797842 60797853 60797854 60797856 60798617 60798618 60798620 60798633 60798637 60798641 60799910 60799917 60799921 60799924 60799925 60799926 60799929 60799935 60799937 60799938 60799947 60800996 60800998 60802135 60802141 60802144 60802568 60802575 60802579 60805453 60805593 60806318 60806320 60807087 60807090 60807091 60807092 60807093 60807095 60807096 60807186 60807187 60807189 60807198 60807199 60807203 60808405 60808407 60808412 60808413 60808416 60808426 60808428 60808430 60808432 60808433 60808436 60810738 60810741 60810742 60810744 60810747 60810748 60810750 60810753 60810755 60810758 60810759 60810 |
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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-1452-2021%22
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