Recall Z-2201-2026 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GL
| Date | May 14, 2026 (initiated Apr 8, 2026) |
| Status | Open, Classified |
| Reason | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 4/8/2026 via email and mail. The notice explained the issue with the device and provided the following: "Recommendations: Review the order of Flex Infusion steps for patients previously programmed in Flex Infusion Mode: Review the Session Report from the prior interrogation. Access the report via the A810 application by communicating with the pump, then navigating to Settings > Reports > Session Long Report, and review the patient s previous programming session. Within Current Settings, confirm that the s |
| Quantity | 10165 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.