Aurora EV-ICD and Clinical EV-ICD — Class II medical device recall Z-0726-2026
Ongoing recall by Medtronic, Inc., reported 2025-12-10, distributed nationwide. There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
| Recall number | Z-0726-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Inc., Mounds View, MN, United States |
| Recall initiated | 2025-10-29 |
| Classified | 2025-11-28 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,591 units |
| UPC / GTIN / UDI-DI | 00763000217891, 00763000217907, 00763000288068, 00763000368463, 00763000368470, 00763000744694 |
| Serial numbers | EVS600011S, EVS600012S, EVS600013S, EVS600014S, EVS600015S, EVS600016S, EVS600027S, EVS600028S, EVS600032S, EVS600033S, EVS600034S, EVS600036S, EVS600038S, EVS600039S, EVS600040S, EVS600044S, EVS600045S, EVS600048S, EVS600049S, EVS600050S, EVS600051S, EVS600052S, EVS600053S, EVS600055S, EVS600056S and 475 more |
Product
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Reason for recall
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
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-0726-2026. 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.