BIOTRONIK Ilestro 7 DR-T — Class II medical device recall Z-1442-2021
Terminated recall by BIOTRONIK Inc, reported 2021-04-28, distributed nationwide. There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Re
| Recall number | Z-1442-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOTRONIK Inc, Lake Oswego, OR, United States |
| Recall initiated | 2021-03-08 |
| Classified | 2021-04-21 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-04-25 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04035479125202 |
| Serial numbers | 60744585, 60744586, 60744588, 60744589, 60744590, 60744591, 60744592, 60744593, 60744594, 60744595, 60744596, 60744597, 60744598, 60744599, 60744600, 60744602, 60744603, 60744605, 60744606, 60744607, 60744609, 60744610, 60744611, 60744612, 60744613 and 475 more |
| Model numbers | 383564 |
Product
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Reason for recall
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1442-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.