Programmers & Remote Monitoring Software Apps: CareLink SmartSync… — Class II medical device recall Z-0241-2020
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2019-11-06. There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccu
| Recall number | Z-0241-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2019-10-03 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Quantity | 874 units |
| Reason classes | software |
| Serial numbers | SPM001018A, SPM001019A, SPM001020A, SPM001021A, SPM001022A, SPM001023A, SPM001024A, SPM001025A, SPM001026A, SPM001027A, SPM001028A, SPM001029A, SPM001030A, SPM001031A, SPM001032A, SPM001033A, SPM001034A, SPM001035A, SPM001036A, SPM001037A, SPM001038A, SPM001039A, SPM001040A, SPM001041A, SPM001042A and 475 more |
Product
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Reason for recall
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
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-0241-2020. 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.