FDA recall Z-1485-2022

Product

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

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-1485-2022