FDA Device recall Z-1456-2021
BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - 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 ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - 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-1456-2021 |
| 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 ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - 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 60916214 60916993 60917005 60917012 60917120 60917122 60917132 60919194 60919199 60919356 6091…Serial Number 60916214 60916993 60917005 60917012 60917120 60917122 60917132 60919194 60919199 60919356 60919358 60919896 60919903 60919907 60921836 60921843 60921850 60921860 60921869 60921870 60921871 60921881 60921886 60921896 60922662 60922664 60922685 60922713 60922714 60922715 60922717 60922720 60922724 60922727 60923062 60923078 60923082 60923111 60923113 60923114 60923115 60923119 60923262 60923268 60923275 60923279 60924561 60924569 60924575 60924581 60924592 60924610 60924613 60924614 60924683 60924836 60924840 60924841 60924843 60924846 60925361 60925362 60925364 60925368 60925382 60925383 60925406 60925408 60925409 60925413 60925419 60925421 60925810 60925816 60926798 60926800 60926806 60926807 60926808 60926809 60926811 60926813 60926820 60926821 60926823 60926825 60926828 60926829 60926830 60927167 60927169 60927171 60927175 60927176 60927178 60927183 60927186 60927187 60927 |
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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-1456-2021%22
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