—#184754

Product

Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

FDA product code: NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031
Affected lot / code info: Serial Numbers: RTP601047S, RTP601055S

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

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

Timeline

Recall initiated: 2020-11-15
Terminated: 2025-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.