FDA-Device2025-12-10Class II
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Medtronic, Inc.
Hazard
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Sold states
Worldwide - US Nationwide distribution.
Affected count
6591 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2026Don't want to check this manually?
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