FDADecember 19, 2017device

Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ...

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

The hazard

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

006431695663470064316956635400643169929760

Recall history

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

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