medical Class II Updated 2021-12-22

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medical Device Identification Cards associated with Astra XT

Recalled Product

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

Hazard / Issue

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."

Issued by

FDA

Distribution: US, Canada, Northern Mariana Islands

Lot/Code Info: Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S UDI 00643169634671, Serial Numbers: RNH612514S

View official government recall

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