Medtronic — Class II medical device recall Z-2125-2016
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2016-07-13. Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After
| Recall number | Z-2125-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2016-05-26 |
| Classified | 2016-07-05 |
| Reported by FDA | 2016-07-13 |
| Terminated | 2016-10-27 |
| Countries outside the US | AE, AT, BE, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, MY, NL, NO, PL, PT, SA, SE, SK, ZA |
| Quantity | 262 |
| Reason classes | software |
| Serial numbers | YDM001132A, YDM001745A, YDM002664A, YDM002701A, YDM003337A, YDM004445A, YDM004921A, YDM005795A, YDM010849A, YDM010853A, YDM011147A, YDM011149A, YDM011272A, YDM012137A, YDM013030A, YDM015178A, YDM015183A, YDM015353A, YDM020290A, YDM020298A, YDM022307A, YDM023936A, YDM032480A, YDM033976A, YDM037712A and 237 more |
| Model numbers | 24950 |
Product
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Reason for recall
Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.
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-2125-2016. 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.