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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2,543
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.
Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighMedtronic Implantable Drug Pumps Recalled for Software Defects
FDA (Devices) · 2025-01-08
- ModerateMedtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump
FDA (Devices) · 2017-04-05
- SevereMedtronic SynchroMed II Software Card Recall for Priming Bolus Function
FDA (Devices) · 2017-03-08
- HighMedtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects
FDA (Devices) · 2025-01-08
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- HighMedtronic A820 myPTM Infusion Pump Software Shows Delayed Patient Response
FDA (Devices) · 2025-04-09