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Recall Observatory FDA recall evidence

Device 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)

Z-0927-2021

November 15, 2020

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 86887
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0927-2021

Official wording

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

Code information: Serial Numbers: RTP601047S, RTP601055S

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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