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FDANovember 15, 2020device

Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR) — Recall Details · AllClear