FDA recall Z-1802-2023

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class I · device

Product

ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators

Reason for recall

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Distribution

US Nationwide - Worldwide Distribution

Key facts

Status: Ongoing
Initiation date: 2023-05-10
Report date: 2023-06-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1802-2023