Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
This recall is currently active, issued November 8, 2021. It was issued by Medtronic Inc., Cardiac Rhythm And Heart Failure (Crhf).
- Recall Initiated
- November 8, 2021
- Recall Number
- Z-0391-2022
- Quantity
- 10 Medical Device Cards
- Firm Location
- Mounds View, MN
- Official Source
- View on FDA website ↗
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.