FDA Device recall Z-1446-2021
BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - 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 Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - 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-1446-2021 |
| 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 Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - 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 60824474 60824475 60824491 60824629 60824642 60824679 60825002 60825013 60825017 60825022 6082…Serial Number 60824474 60824475 60824491 60824629 60824642 60824679 60825002 60825013 60825017 60825022 60825023 60825049 60825055 60825699 60825703 60825709 60825717 60825726 60825729 60825734 60825740 60825901 60825906 60825926 60825945 60826501 60826504 60826652 60826660 60826693 60826699 60826716 60826726 60826735 60831890 60833123 60833702 60834136 60834474 60834512 60834525 60834535 60834869 60835629 60835640 60835650 60835657 60835662 60835664 60835668 60835978 60835998 60836218 60837185 60837193 60837213 60837218 60837233 60837422 60837427 60837832 60838223 60838230 60838468 60838496 60838499 60838865 60838866 60838870 60840477 60840585 60840833 60840835 60840836 60840837 60840839 60840840 60840904 60841110 60841125 60841445 60841452 60841459 60841461 60842559 60843499 60843500 60843793 60843804 60843813 60843814 60843818 60843825 60843838 60843912 60843920 60843925 60844777 60844 |
|---|
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-1446-2021%22
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