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FDANovember 8, 2021device

Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

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

The hazard

The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

0076300010895300643169634671

Recall history

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

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