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FDA-Device2026-05-20Class IIPROCESSING DEFECT

Medtronic SynchroMed Flex Infusion A810 Clinician Programmer software recalled for incorrect infusion scheduling

Medtronic
OTHERNationwide distribution

Medtronic SynchroMed programmer software recalled for scheduling error

A software issue in the A810 Clinician Programmer App can cause infusion steps to display out of order in rare cases. When this happens, the SynchroMed Flex infusion pump may not deliver medication at the intended time, or not deliver it at all. The issue affects specific clinician tablet models running software versions 1.x and 2.x.

  • If you use or manage a SynchroMed Flex infusion pump with one of the affected clinician tablets, contact your healthcare provider or Medtronic immediately.
  • Do not program new infusion schedules using the A810 app until you receive updated software or guidance from Medtronic.
  • Verify with your care team that your current infusion schedule is delivering medication as intended.
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.

Sold states
Worldwide distribution.
Affected count
10165 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2026

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