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MEDICAL DEVICE RECALLMODERATE

Medtronic SynchroMed Flex Infusion Mode A810 Software

Medtronic is recalling A810 software for SynchroMed pumps due to a display error that may cause incorrect or missed medication delivery.

What to do

Clinicians should verify the order of infusion steps on the screen before confirming any programming changes. Contact Medtronic Neuromodulation for further instructions regarding software updates or mitigation steps.

Recalled
Listed
Updated
Recall No.
Z-2201-2026
Agency
FDA
Firm
Medtronic Neuromodulation
Recall ID
98750
Status
ONGOING

Recall at a glance

Quantity recalled
10165 units

Why it was recalled

Medtronic is recalling the A810 Clinician Programmer software application used with SynchroMed infusion pumps due to a software error that may cause infusion steps to be displayed out of chronological order. This error can result in the pump failing to deliver medication at the intended time or failing to deliver it entirely. The affected software is loaded on Clinician Tablet models CT900A, CT900B, CT900C, CT900D, CT900E, and CT900F.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUDI-DI
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 CT90000643169890923, 00643169890947, 00763000447090, 00763000729141, 00763000737290, 00763000926144, 00763000984649
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on00643169890923, 00643169890947, 00643169890961, 00763000077730, 00763000094027, 00763000421007, 00763000447090, 00763000729141, 00763000737290, 00763000926144, 00763000984649

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification