Medical Device Identification Cards associated with Sprint Quattro… — Class II medical device recall Z-0390-2022
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-0390-2022 |
|---|---|
| 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 | 187 medical |
| UPC / GTIN / UDI-DI | 00613994718877, 00643169309784, 00643169550919 |
| Serial numbers | TDL002704V, TDL010685V, TDL016557V, TDL016558V, TDL016560V, TDL046363V, TDL098796V, TDL187462V, TDL192485V, TDL199017V, TDL276334V, TDL294118V, TDL298584V, TDL298585V, TDL312450V, TDL315797V, TDL315812V, TDL316169V, TDL316181V, TDL316186V, TDL321171V, TDL321443V, TDL321456V, TDL323585V, TDL326110V and 162 more |
Product
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
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-0390-2022. 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.