Recall Z-0522-2024 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Inc.
Medtronic SynchroMed, Model A10
| Date | Dec 9, 2023 (initiated Jul 13, 2020) |
| Status | Completed |
| 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. |
| Root cause | Software Design Change |
| Action | Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342. |
| Quantity | 2543 units |
| Distribution | Foreign Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.