Medtronic SynchroMed — Class II medical device recall Z-0522-2024
Completed recall by Medtronic Inc., reported 2023-12-20. The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter ran
| Recall number | Z-0522-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Mounds View, MN, United States |
| Recall initiated | 2020-07-13 |
| Classified | 2023-12-09 |
| Reported by FDA | 2023-12-20 |
| Quantity | 2,543 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00643169771031 |
| Model numbers | A10 |
Product
Medtronic SynchroMed, Model A10
Reason for recall
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
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-0522-2024. 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.