FDA Device recall Z-1448-2021
BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventr…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventr… 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-1448-2021 |
| 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,DR-T, DF-1,REF 390064, UDI: 04035479126926 - 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 60717860 60722974 60725417 60725753 60726857 60726883 60726910 60727193 60727205 60727215 6072…Serial Number 60717860 60722974 60725417 60725753 60726857 60726883 60726910 60727193 60727205 60727215 60727225 60727234 60727253 60727408 60727417 60728042 60728047 60728050 60728804 60728809 60728810 60728811 60728813 60728825 60728852 60728854 60728857 60728865 60728888 60728913 60728915 60728936 60728989 60728998 60729019 60729022 60729047 60729049 60729051 60729056 60729065 60729068 60729084 60729087 60729120 60729122 60729804 60730307 60730321 60730325 60730333 60730337 60730356 60730599 60730623 60731392 60731401 60731422 60738027 60738986 60740536 60740540 60740542 60740568 60740569 60740599 60740965 60740982 60740988 60741013 60741028 60741031 60741276 60741295 60741307 60741310 60741338 60741623 60741633 60741653 60741734 60741752 60741761 60741781 60741797 60741799 60744245 60744246 60744251 60744252 60744255 60744256 60744258 60744259 60744261 60744285 60744286 60744288 60744 |
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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-1448-2021%22
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