FDAJune 22, 2022device

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4

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

The hazard

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

What to do

FDA enforcement status: Ongoing

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

0076300017849900763000178505007630001785120076300017852900763000178376007630001783830076300017839000763000178406

Recall history

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

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