—#190445

Product

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

FDA product code: NVZ — Pulse Generator, Permanent, Implantable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P920015
Affected 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

Why it was recalled

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."

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: US, Canada, Northern Mariana Islands

Timeline

Recall initiated: 2021-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.