FDA Announces Smiths Medical ASD Inc.’s Recall of Medfusion Model 3500 Syringe Pump

March 06, 2024

On March 5, 2024, the U.S. Food and Drug Administration (FDA) announced (https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-asd-inc-recalls-medfusion-model-3500-syringe-pump-due-issues-associated-earlier) that Smiths Medical ASD Inc. is recalling its Medfusion model 3500 syringe pump because of issues associated with earlier software versions, including high-priority alarms during motor issues, wrong infusion restarts, screen locks, bolus interruptions, incorrect dose displays, low doses, motor errors, wrong settings recall, corrupt configurations, auto locks, and toolbox issues with loading dose time values. If a device has undetected issues, it may fail and delay, interrupt, or not deliver the therapy per the programmed setting.

FDA update

FDA identified it as a class I recall, where use of the device may result in serious injury or death. To date, FDA received a report of one related injury and no deaths.

The recall affects 85,961 Medfusion Model 3500 syringe pumps (product codes FRN (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=205366)), which were distributed in the United States from August 9, 2002–August 15, 2023.

On December 19, 2023, Smiths Medical sent an urgent medical device correction letter requesting customers to:

Customers with questions about the recall should contact Smiths Medical at 866-216-8806. Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).


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