FDA recall Z-1480-2022

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

Product

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Reason for recall

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Distribution

US Nationwide distribution in the states of Indiana and CA.

Key facts

Status
Ongoing
Initiation date
2020-11-05
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2022