FDA DeviceClass IINotable

FDA Recall: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on

Date: 2026-05-20
Brand: Medtronic Neuromodulation
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

10165 units

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