FDA recall Z-0726-2026

Medtronic, Inc. · Class II · device

Product

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-10-29
Report date
2025-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2026