# FDA recall Z-0391-2022

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2021-11-08.

## Product

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

## 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

## Key facts

- **Recall number:** Z-0391-2022
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-08
- **Report date:** 2021-12-22
- **Termination date:** 2026-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0391-2022

## Citation

> AI Analytics. FDA recall Z-0391-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0391-2022. Source: US FDA. Licensed CC0.

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