Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Reported: December 10, 2025 Initiated: October 29, 2025 #Z-0726-2026
Product Description
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.
Details
- Recalling Firm
- Medtronic, Inc.
- Units Affected
- 6591 units
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4. Recalled by Medtronic, Inc.. Units affected: 6591 units.
Why was this product recalled? ▼
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0726-2026.
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