FDA Device recall Z-1443-2021
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ven…
- FDA Device
- Class II
- terminated
- Published 2021-04-28
On 2021-04-28 the FDA classified a Class II recall of BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ven… 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-1443-2021 |
| 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 VR-T, DF-1, REF 383578, UDI: 04035479125349 - 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 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 6071…Serial Number 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 60715282 60715285 60715286 60715287 60715288 60715292 60715293 60715296 60715299 60715300 60715301 60716193 60716194 60716195 60716196 60716197 60716198 60716199 60716201 60716203 60716204 60716205 60716208 60716210 60716597 60716598 60716599 60716600 60716603 60716604 60716606 60716608 60716611 60716612 60716613 60716615 60716616 60716647 60716648 60716651 60716652 60716653 60716654 60716655 60716656 60717982 60717984 60717985 60717988 60717989 60717994 60717995 60717996 60717998 60717999 60718001 60718002 60718003 60718004 60718005 60718006 60718007 60718008 60718010 60718013 60718014 60718015 60718017 60718020 60718024 60718026 60718027 60718028 60718030 60718031 60718032 60718033 60718035 60718039 60718043 60718044 60718045 60718046 60718048 60718054 60718055 60718059 60718061 60718 |
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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-1443-2021%22
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