Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aurora EV-ICD and Clinical EV-ICD Recalled by Medtronic, Inc. Due to There is a potential for delayed time to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic, Inc. directly.
Affected Products
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Quantity: 6591 units
Why Was This Recalled?
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic, Inc.
Medtronic, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report