FDA-Device2025-12-10Class IIPROCESSING DEFECT
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Hazard
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Intended for
Adults
Illnesses reported
None reported
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-0726-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.