FDADecember 19, 2017device

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. D...

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

006431697057770064316992953100643169543362006431699295620064316954341600643169705760

Recall history

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

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