Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
- Recall Initiated
- November 8, 2021
- Recall Number
- Z-0391-2022
- Quantity
- 10 Medical Device Cards
- Firm Location
- Mounds View, MN
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
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
Root Cause
Error in labeling
Action Taken
On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.