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 CT
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | April 08, 2026 |
| Reported | May 20, 2026 |
| Recalling firm | Medtronic Neuromodulation |
| Country / region | United States MN |
Hazard
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.
Product description
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 GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Affected products
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET U