FDA Device recall Z-0522-2024
Medtronic SynchroMed, Model A10
- FDA Device
- Class II
- completed
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of Medtronic SynchroMed, Model A10 by Medtronic, citing 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: Cath….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0522-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-07-13 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | n/a |
Product
Medtronic SynchroMed, Model A10
Reason
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.
Identifiers
| code_info | GTIN 00643169771031, All serial numbers with software version 1.1.300. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0522-2024%22
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