FDA recall Z-0928-2021

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

Product

Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

Reason for recall

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

Distribution

Distribution to US states of GA, PA, NJ, and France

Key facts

Status: Terminated
Initiation date: 2020-11-15
Report date: 2021-02-03
Termination date: 2025-12-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2021