SynchroMed Model A10 Infusion Pump Software Display Error
Medtronic is recalling 2,543 SynchroMed Model A10 infusion pumps with software version 1.1.300 due to missing decimal separators on parameter display screens. The omission could lead to misinterpretation of dosing parameters.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a software display defect on a critical medical device with potential for dosing error, but no injuries or adverse events have been reported, placing it in the High severity category per the rubric.
Plain-English summary
Medtronic Inc. is recalling 2,543 SynchroMed Model A10 infusion pumps (GTIN 00643169771031) equipped with software version 1.1.300. The recall applies globally to devices distributed internationally.
The affected software is missing a decimal separator (comma) in parameter range guidance values displayed on programming screens, including Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm screens. This formatting omission could lead users to misinterpret the intended parameter values during device programming.
Healthcare facilities and individuals using affected units should contact Medtronic directly for updated software or device replacement guidance. No injuries or adverse events have been reported as of the recall date.
The recalled product
- Product
- Medtronic SynchroMed, Model A10
- Manufacturer
- Medtronic Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- mis-labeling
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00643169771031
- All serial numbers with software version 1.1.300.
Distribution
Distribution scope not specified by the agency.
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