FDA Device recall Z-1441-2021
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and vent…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and vent… 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-1441-2021 |
| 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 Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - 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 numbers: 60705317 60707977 60708912 60709157 60709393 60709408 60709992 60710002 60710004 60710006 607…serial numbers: 60705317 60707977 60708912 60709157 60709393 60709408 60709992 60710002 60710004 60710006 60710009 60710010 60710202 60710203 60711081 60711093 60711108 60711123 60711124 60711130 60711285 60711293 60711297 60711301 60711624 60711628 60711633 60711641 60711653 60711655 60711656 60711658 60711659 60711660 60711661 60712136 60712137 60712142 60712164 60712165 60712171 60712212 60712362 60712364 60712366 60712381 60712433 60712434 60712440 60712453 60712454 60712455 60712456 60712632 60712635 60712662 60712667 60712668 60712677 60712678 60712679 60712680 60712681 60712683 60712688 60712690 60713619 60713623 60713624 60713625 60713626 60713628 60713629 60713630 60713631 60713877 60713878 60713879 60713881 60713882 60713883 60713887 60713891 60713894 60713899 60713906 60713907 60713908 60713910 60713911 60713913 60713917 60713922 60713928 60713929 60713935 60713939 60713940 6071 |
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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-1441-2021%22
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