On March 5, 2024, the U.S. Food and Drug Administration (FDA) announced 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 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), 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:
- Locate all affected pumps and ensure all users of these devices are immediately made aware of this notification and proposed mitigations.
- Confirm all pumps have the most recent Medfusion software installed.
- Complete the response form provided and return it to smithmedical6114@sedgwick.com within 10 days of receiving the letter.
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.