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Recall

Medtronic Neuromodulation: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CL Recall

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. Product details: 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 CLIN...

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Agency
FDA
Record ID
Z-2201-2026
Canonical
https://claimwatch-mvp.vercel.app/item/medtronic-neuromodulation-medtronic-synchromed-flex-infusion-mode-a810-clinician-programme/

What happened?

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. Product details: 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 CLIN...

Who may be affected?

Worldwide distribution.

What should consumers do?

Affected quantity: 10165 units

Official source

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