Z-0391-2022 Class II Terminated
FDA device recall Z-0391-2022 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on November 8, 2021 and is designated Class II. Reason for recall: 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.… The recall status is terminated (terminated May 4, 2026). Affected quantity: 10 Medical Device Cards.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 8, 2021
- Termination Date
- May 4, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 Medical Device Cards
Product Description
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Reason for Recall
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."
Distribution Pattern
US, Canada, Northern Mariana Islands
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