Medtronic SynchroMed Flex Infusion Software Issue: Steps May Not Program Correctly
Medtronic recalls certain SynchroMed Flex Infusion Programmer software versions that may display infusion steps out of order, causing missed medication schedules. Affected devices include specific clinician tablets with model numbers CT900A through CT900F and software versions 1.x and 2.x.
Lower-risk 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.
Contact the company
What happened, in plain English
Medtronic is recalling specific versions of their SynchroMed Flex Infusion Programmer software that may display medication steps out of order when programming the pump. This could cause the scheduled doses to not be delivered at the intended times. The issue is rare but requires attention to ensure proper medication timing. Read more at govinfonow.com/recall/49533-medtronic-synchromed-flex-infusion-software-issue-steps-may-not-program.
Source Summary by GovInfoNow · govinfonow.com/recall/49533-medtronic-synchromed-flex-infusion-software-issue-steps-may-not-program · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2201-2026
Cite this page
“Medtronic SynchroMed Flex Infusion Software Issue: Steps May Not Program Correctly.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49533-medtronic-synchromed-flex-infusion-software-issue-steps-may-not-program. Based on FDA recall #Z-2201-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2201-2026%22&limit=1).
Why it’s dangerous
The software issue causes the infusion steps to sometimes appear in the wrong order when programming the pump. This means the medication schedule might not be delivered at the intended times, potentially leading to missed doses. However, this is a rare occurrence and does not cause immediate harm.
Who’s affected
Patients using Medtronic SynchroMed pumps with the affected software versions on the listed clinician tablets are most at risk. Healthcare providers who program these pumps daily should check their software versions.
How to tell if you have this one
Check if your device is one of the listed clinician tablets (CT900A to CT900F) with the specific model numbers and serial numbers provided in the recall notice. The software version is 1.x or 2.x.
- Brand
Medtronic- Product
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version by checking the device settings or documentation. The affected versions are 1.x and 2.x.
Update Software
If your software is affected, contact Medtronic to update to a newer version that resolves this issue.
How this recall unfolded
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the device?
No, you do not need to stop using the device. The issue is rare and can be resolved by updating the software.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2201-2026 (April 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2201-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.