Reported Dec 10, 2025 · Ongoing
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…
Medtronic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic, Inc. · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Lot codes and dates
- UDI-DI
007630003684700076300036846300763000217907007630002178910076300028806800763000744694
- Serial Numbers
2,953 of 2,953 codes
EVS600036SEVS600038SEVS600034SEVS600044SEVS600033SEVS600048SEVS600049SEVS600139SEVS600039SEVS600040SEVS600056SEVS600140SEVS600075SEVS600149SEVS600060SEVS600157SEVS600032SEVS600154SEVS600161SEVS600045SEVS600050SEVS600150SEVS600061SEVS600064SEVS600065SEVS600178SEVS600201SEVS600058SEVS600180SEVS600168SEVS600156SEVS600057SEVS600212SEVS600164SEVS600155SEVS600167SEVS600134SEVS600209SEVS600177SEVS600170SEVS600055SEVS600220SEVS600236SEVS600141SEVS600166SEVS600254SEVS600211SEVS600234SEVS600142SEVS600357SEVS600353SEVS600210SEVS600354SEVS600218SEVS600364SEVS600348SEVS600374SEVS600369SEVS600384SEVS600343S
- UDI-DI
- Amount recalled
- 6591 units
Where it was sold
- Nationwide
Why it was recalled
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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