Home / Recalls / Medical Devices
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product
Recalled December 10, 2025 · FDA recall Z-0726-2026 · Medtronic
Hazard
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. · FDA Class II
Units
6591 units
Sold at
Worldwide - US Nationwide distribution.
Description
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Product
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Manufacturer(s)
Medtronic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →