FDA recall Z-1489-2022

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

Product

Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4

Reason for recall

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Distribution

Worldwide Distribution

Key facts

Status: Ongoing
Initiation date: 2022-06-22
Report date: 2022-08-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1489-2022