FDAJune 22, 2022device

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

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

007630001784510076300017847500763000380380007630001784680076300017848200763000380397007630001783380076300017835200763000380366

Recall history

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

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