Medtronic recalls SynchroMed Model A10 devices with software version 1.1.300 due to missing decimal separator in parameter displays, potentially causing misinterpretation of values.
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
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📍Recalling firmMedtronic Inc.8200 Coral Sea St Ne · Mounds View, MN 55112-4391
“Medtronic SynchroMed A10 Software Issue: Missing Decimal Separator.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64731-medtronic-synchromed-a10-software-issue-missing-decimal-separator. Based on FDA recall #Z-0522-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0522-2024%22&limit=1).
The FDA announced on July 13, 2020, that Medtronic Inc. is recalling the Medtronic SynchroMed, Model A10 implantable infusion pump. The hazard involves software version 1.1.300 missing a decimal separator for parameter range guidance values on programming screens.
How to tell if you have it
Brand: Medtronic
Product: Medtronic SynchroMed, Model A10
UPC: 00643169771031
Software version: 1.1.300
Units affected: 2543
The hazard
The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens, including Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since September 10, 2017. Other recent recalls of similar products include the Medtronic Sphere-9 Catheter Recall (March 11, 2026), the Medtronic Abre Venous Stent Recall (December 4, 2025), and the Medtronic EVX 60 Series recall (October 29, 2025). Additionally, a Medtronic SynchroMed Flex Infusion Software Issue was reported on April 8, 2026.
How to tell if you have this one
Check if your Medtronic SynchroMed Model A10 device has software version 1.1.300. The device can be identified by its GTIN 00643169771031 or serial number.
Brand
Medtronic
Product
Medtronic Inc. recalls Medtronic SynchroMed, Model A10
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version by checking the device settings or documentation.
How this recall unfolded
Recall timeline
FDA published this recall 3.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0522-2024 (July 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0522-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.