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Recall Observatory FDA recall evidence

Device product

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

Z-0391-2022

November 08, 2021

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 89054
Status
Terminated
Classification
Class II
Quantity
10 Medical Device Cards
Official record key
device-enforcement:Z-0391-2022

Official wording

Reason: 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."

Code information: 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

Distribution pattern: US, Canada, Northern Mariana Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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."