Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-0928-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 15, 2020

Date Posted: February 3, 2021

Recall Number: Z-0928-2021

Event ID: 86887

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial Numbers: RSN600251S, RSN600656S

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated