The Recall Desk
ModerateFDA (Devices)·Z-0391-2022·Announced 2021-12-22

Astra XT DR Patient Identification Cards Printed with Incorrect MR Statement

Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall of a labeling error on patient identification cards with an incorrect statement about device MR safety status. No illnesses, injuries, or deaths have been reported, and the hazard is a documentation/labeling issue requiring correction.

Plain-English summary

Medtronic Inc. is recalling Medical Device Identification Cards associated with the Astra XT DR implantable pulse generator. Some of the identification cards were printed with an erroneous statement on the back stating "This patient has a complete MR conditional system implanted."

The erroneous statement on the identification cards requires correction to ensure accurate device information. The identification cards are provided to patients to document information about their implanted device.

The affected identification cards were distributed in the United States, Canada, and the Northern Mariana Islands. Approximately 10 identification cards with specific Astra XT DR product numbers and serial numbers are included in the recall.

Patients who have received affected identification cards should contact Medtronic or their healthcare provider regarding replacement cards with correct information. The FDA has classified this recall as Class II.

The recalled product

Product
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Patient Identification Card
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distribution scope not specified by the agency.

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