Medtronic Neuromodulation: Pump, Infusion, Implanted, Programmable
Recall Summary Medtronic is recalling clinician programmer tablets (models CT900A through CT900F) used to program SynchroMed Flex infusion pumps because of a software issue that can cause medication delivery schedules to display in the wrong order. When this occurs, patients may not receive their medication doses at the intended times. This recall affects clinicians worldwide who use these devices to program implanted infusion pumps.
- Recalling firm
- Medtronic Neuromodulation
- Product
- 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
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-08
- Status
- Open, Classified
- Distribution
- Worldwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a92d3b12-22f8-4d64-a1a4-0552afe4b99d