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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 can cause incorrect or failed infusion delivery.

What to do

Clinicians should verify the order of infusion steps on the screen before finalizing any programming. Contact Medtronic for software update instructions or further guidance regarding the use of the A810 application.

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

Why it was recalled

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.

How to identify it

UPC 00643169890923 00643169890947 00763000447090 00763000729141 00763000737290 00763000926144 00763000984649

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification