U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Medical Device Recalls
  5. Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error
  1. Medical Device Recalls

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Medfusion Syringe Pumps
    • Model 3500, firmware version 6.0.0
      Models 3500-0600-00, -01, -249, -51, -82
    • Model 4000, firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0
      Models 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231
  • Manufacturing Dates: 5/2002 to present
  • Distribution Dates: 11/1/2013 to present
  • Devices Recalled in the U.S.: 46,395
  • Date Initiated by Firm: June 26, 2020

Device Use

The Smiths Medical Medfusion Syringe Pump delivers blood, blood products, prescribed drugs, and other fluids into a patient's body in a controlled manner. Syringe pumps are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for the adult population.

Figure 1. Pictures of the Medfusion 3500 and 4000 Syringe Pumps.

Reason for Recall

Smiths Medical is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Use of the affected syringe pumps may cause serious adverse health consequences including death.

There have been four complaints regarding this device issue including one serious injury. There have been no deaths.

Who May be Affected

  • Health care providers using the affected Smiths Medical Medfusion Syringe Pump
  • Patients who receive fluids or medications delivered by the affected Smiths Medical Medfusion Syringe Pumps

What to Do

On June 26, 2020, Smiths Medical sent an Urgent Medical Device Recall notice to all affected customers and provided the following instructions:

  • Locate all Medfusion® 3500 and 4000 Syringe Pumps in possession and verify the firmware version to determine if the pump(s) is impacted by this notice.
  • Ensure all personnel who may utilize the pump are aware of this recall.
  • For any reason, when a bolus or loading dose delivery is interrupted, cancel the bolus or loading dose and begin a new infusion to avoid potential inappropriate delivery.
  • Complete and return the response form attached to the notice and email it to Smiths Medical at [email protected] within 10 days of receipt.
    • Distributors share the notification with customers who have received the affected product and ask each customer to complete the response form contained in the notice and return to back to the distributor.

Contact Information

Customers who have questions about this recall may contact Smiths Medical by emailing [email protected].

Additional Resources

How do I report a problem?

Health care 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 using an online form, regular mail, or FAX.

Back to Top