Recall Z-0726-2026— Medtronic, Inc.

Name: FDA recall Z-0726-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-29

Class II · Ongoing

Class II FDA medical device recall by Medtronic, Inc., initiated 2025-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4. Reason: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur..

Recalling firm: Medtronic, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-29
Firm location: Mounds View, MN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.