FDA recall, , Moderate risk
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application
The software may display infusion steps out of order, causing the schedule not to be delivered at the intended time.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Neuromodulation of Minneapolis, Minnesota, recalled the Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application due to a software issue.
The application, loaded on PROG CT900A CLINICIAN TABLET US, PROG CT900B CLINICIAN TABLET EU -UK, PROG CT900C CLINICIAN TABLET UK, PROG CT900D CLINICIAN TABLET GLOBAL, PROG CT900E CLINICIAN TABLET GLBL SMSNG, and PROG CT900F CLINICIAN TABLET GLBL SMSNG, may display infusion steps out of order in rare cases.
If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all. The company began the recall on April 8, 2026, and it was added to the FDA's Enforcement Report on May 14, 2026, with worldwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on
- UDI-DI
- 00643169890923
- 00643169890947
- 00643169890961
- 00763000077730
- 00763000094027
- 00763000421007
- 00763000447090
- 00763000729141
- 00763000737290
- 00763000926144
- 00763000984649
Prog CT900A Clinician Tablet US
Prog CT900B Clinician Tablet EU -UK
Prog CT900C Clinician Tablet UK
Prog CT900D Clinician Tablet Global
Prog CT900E Clinician Tablet GLBL Smsng
Prog CT900F Clinician Tablet GLBL Smsng
Recall details
- Company began the recall
- Sold in
Worldwide distribution.
- Company
- Medtronic NeuromodulationMinneapolis, Minnesota
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98750
- Recall number
- Z-2201-2026
- Quantity recalled
- 10165 units
All recalls from Medtronic Neuromodulation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
