FDA Device recall Z-1453-2021
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing an…
- 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 DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing an… 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-1453-2021 |
| 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 DF4 ProMRI, REF 392423, UDI: 04035479128913 - 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 60826231 60826274 60826822 60834578 60834590 60834592 60834595 60834602 60834610 60834618 6083…Serial Number 60826231 60826274 60826822 60834578 60834590 60834592 60834595 60834602 60834610 60834618 60834627 60834628 60834640 60835705 60835712 60836005 60836015 60836158 60836479 60836767 60836769 60836770 60836771 60836775 60836776 60836777 60836779 60836782 60836787 60836788 60836802 60836809 60836812 60836824 60836830 60836935 60836941 60836944 60836963 60836979 60836985 60837879 60837889 60837892 60837919 60837922 60837924 60837928 60837932 60838019 60838020 60838056 60838060 60838064 60838082 60838095 60838106 60838107 60838110 60838382 60838656 60838668 60838670 60838673 60838674 60838680 60838683 60838689 60838704 60838941 60839108 60839144 60839263 60839808 60839811 60839827 60839830 60839833 60839838 60839841 60839845 60839857 60839863 60839868 60839871 60839873 60839874 60839875 60840403 60840404 60840406 60840411 60840414 60840420 60840421 60840422 60840444 60840454 60840 |
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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-1453-2021%22
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