Medical Device Identification Cards associated with Astra XT DR… — Class II medical device recall Z-0391-2022
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-12-22, distributed in MP. The back of some Medical Device Identification Cards provided to patients were printed with an erroneous state
| Recall number | Z-0391-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2021-11-08 |
| Classified | 2021-12-16 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2026-05-04 |
| Distributed | MP |
| Countries outside the US | CA |
| Quantity | 10 medical |
| UPC / GTIN / UDI-DI | 00643169634671, 00763000108953 |
| Serial numbers | RNH612514S, RNH633755S, RNH634608S, RNH635040S, RNH636809S, RNH638740S, RNH642593S, RNH645452S, RNH648107S, RNH655287S |
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."
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0391-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.