Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 29, 2025 |
| Reported | December 10, 2025 |
| Recalling firm | Medtronic, Inc. |
| Country / region | United States MN |
Hazard
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Affected products
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
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