---
title: "Medical Device Identification Cards associated with Astra XT DR Implantable p... — FDA record Z-0391-2022 | Is It on Recall"
description: "The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: \"This patient has a co"
url: https://isitonrecall.com/recall/fda-device-z-0391-2022-medical-device-identification-cards-associated-with-astra-xt-dr-implantable-pulse-generator/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator — FDA record Z-0391-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 8, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
- **Reason**: 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."
- **Classification**: Class II
- **Recalling firm**: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Quantity**: 10 Medical Device Cards
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0391-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0391-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US, Canada, Northern Mariana Islands

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 22, 2021
- **Recall initiation date**: Nov 8, 2021
- **Center classification date**: Dec 16, 2021
- **Termination date**: May 4, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0391-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) records](https://isitonrecall.com/brand/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/)