Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2021 - (Recall #: Z-0391-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 8, 2021

Date Posted: December 22, 2021

Recall Number: Z-0391-2022

Event ID: 89054

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."

Status: Ongoing

Product Quantity: 10 Medical Device Cards

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

Voluntary or Mandated:

Voluntary: Firm initiated