FDAApril 8, 2026device
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;...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic neuromodulationmedtronic
UPCs
006431698909230064316989094700643169890961007630000777300076300009402700763000421007
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor2026-05-13
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
- FDAOctopus 4 Tissue Stabilizer, Model 294002026-05-12
- FDABoston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: T...2026-04-29
- FDABoston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STA...2026-04-29
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