Medfusion 3500-0600-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,041 adverse event reports that list this exact device (DI 10610586041242), received between Mar 24, 2017 and Sep 30, 2026 — classified as 2,041 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (949 reports).

2 FDA recall records name this device's identifier, 2 still open.

16 other recalls cover devices cleared under the same FDA submission (K111386); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 19, 2023Class IIOpen, Classified

   Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

   Z-1540-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 16, 2023Class IIOpen, Classified

   A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

   Z-0078-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,041 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952784 ↗
• MalfunctionSep 9, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692850 ↗
• MalfunctionSep 9, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691525 ↗
• MalfunctionAug 14, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50262914 ↗
• MalfunctionAug 12, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222757 ↗
• MalfunctionAug 12, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222551 ↗
• MalfunctionAug 4, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129161 ↗
• MalfunctionJul 9, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25768317 ↗
• MalfunctionJun 23, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD A ACU WATCHDOG FAILURE, WITH VERSION 6.0.3 DURING TESTING. IT WAS CONFIRMED DURING INSPECTION OF A RETURNED PUMP THAT ACU WATCHDOG FAILURE ERROR DOES APPEAR IN EVENT LOG. THE FAILURE MODE WAS FOUND IN NON-CLINICAL CONDITION. HOWEVER, IF THE ISSUE REOCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599839 ↗
• MalfunctionJun 18, 2026Failure to Deliver

  IT WAS REPORTED THAT THE SYRINGE WAS NOT DISPENSING EVEN THOUGH THE PUMP INDICATED THAT IT WAS. THE EVENT OCCURRED DURING MONITORING. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552295 ↗
• MalfunctionJun 9, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXPERIENCED AN ISSUE RELATED TO THE PLUNGER ASSEMBLY, ACCOMPANIED BY AN ERROR INDICATING THAT THE PLUNGER WAS NOT IN THE CORRECT POSITION. THE EVENT OCCURRED DURING SETUP, WITH NO PATIENT INVOLVEMENT AND NO REPORTED HARM. THE ASSOCIATED ERROR MESSAGE IS CLASSIFIED AS HIGH PRIORITY AND, IF IT OCCURS DURING ACTIVE USE, WOULD INTERRUPT THE INFUSION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444281 ↗
• MalfunctionJun 1, 2026Mechanical Problem

  IT WAS REPORTED THAT THE STEPPER MOTOR IS NOT ADVANCING. THE EVENT OCCURRED DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356045 ↗
• MalfunctionMay 22, 2026False Alarm

  IT WAS REPORTED THAT THE PUMP HAD A FALSE OCCLUSION ERROR DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE WAS DUE TO A FAULTY SQUARE SHAFT AND POTENTIOMETER POSITION SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255163 ↗
• MalfunctionApr 29, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING SETUP THAT THE DEVICE ASKED FOR THE BIOMED PASSCODE, GIVING THE AUDIBLE ALARM POST ERROR, AND SYSTEM FAILURE ACU WATCH DOG, HAS HAPPENED TWICE SINCE THEY GOT IT BACK FROM REPAIR. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034889 ↗
• MalfunctionApr 22, 2026Failure to Pump

  IT WAS REPORTED THAT THE PUMP DISPLAYED TRAVEL COURSE ERROR/PLUNGER LEVER. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956241 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SET UP THE PUMP HAD A MOTOR RATE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912167 ↗
• MalfunctionApr 16, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED A BIOMED ERROR CODE AND ACU WATCHDOG ERROR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898749 ↗
• MalfunctionApr 8, 2026Circuit Failure; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING ACU WATCHDOG ERROR/SUPERCAP POST ERROR. THE EVENT OCCURRED DURING SET UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821787 ↗
• MalfunctionApr 7, 2026Electrical /Electronic Property Problem; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP CONTINUED TO HAVE MAINBOARD ISSUES, INCLUDING ACU POWER STROBE FAILURE AND ACU WATCHDOG FAILURE. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800042 ↗
• MalfunctionApr 6, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP HAD A PRIMARY FAILURE FOR THE PRIMARY AUDIBLE ALARM BACKGROUND TEST AND SYSTEM FAILURE FOR ACU WATCHDOG FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790203 ↗
• MalfunctionMar 26, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE PUMP EXHIBITED THREE PRIMARY AUDIBLE ALARMS POST AND WATCHDOG FAILURES DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699296 ↗
• MalfunctionMar 23, 2026Failure to Infuse

  THE CUSTOMER REPORTED THAT PUMP FAILED PREVENTIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT AND PATIENT HARM. EVALUATION OF RETURNED DEVICE IDENTIFIES TRAVEL COARSE ERROR WHICH CAN LEAD TO INTERRUPTION OF THERAPY WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662533 ↗
• MalfunctionMar 17, 2026Failure to Infuse

  IT WAS REPORTED THAT THE PUMP SHOWED ACU WATCHDOG FAILURE AND PRIMARY AUDIBLE ALARM BGND DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617815 ↗
• MalfunctionMar 16, 2026Circuit Failure

  IT WAS REPORTED THAT THE AIR CONTROL UNIT (ACU) HAD EXPERIENCED WATCHDOG FAILURES MULTIPLE TIMES, THE PRIMARY AUDIBLE ALARM HAD ALARMED, AND SEVERAL OTHER ERRORS HAD OCCURRED. PER REPORTER, THIS EVENT HAD OCCURRED DURING POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605993 ↗
• MalfunctionMar 11, 2026Device Sensing Problem

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE DEVICE HAD ERROR MESSAGE "CHECK SYRINGE PLUNGER SENSOR" AND ALARM DURING POWER UP.¿ DURING DEVICE EVALUATION THE ALLEGATION WAS CONFIRMED DUE TO NORMAL PRODUCT CHARACTERISTICS OF THE EAR CLIP CAUSING PLUNGER FLIPPER INTERFERENCE. THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE UNIT IS BEING RETURNED FOR A POTENTIAL REPEAT REPAIR; IT WAS RECENTLY SERVICED FOR A MOTOR RATE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568556 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111386. One submission often covers many models, so check the product and lot details in each record.

• Z-0864-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 4000 syringe pump
• Z-1543-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
• Z-1541-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4
• Z-0079-2024 · Aug 16, 2023 · Open, Classified
  Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k)
• Z-0272-2023 · Oct 10, 2022 · Open, Classified
  Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environme
• Z-1271-2022 · Apr 18, 2022 · Open, Classified
  Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4
• Z-2734-2020 · Jun 26, 2020 · Open, Classified
  Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
• Z-2735-2020 · Jun 26, 2020 · Open, Classified
  Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
• Z-0610-2020 · Oct 28, 2019 · Terminated
  Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to me
• Z-2554-2019 · Oct 15, 2018 · Terminated
  Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1,
• Z-2662-2018 · Apr 13, 2018 · Terminated
  Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
• Z-1134-2018 · Nov 13, 2017 · Terminated
  Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion r
• Z-0313-2018 · Aug 22, 2017 · Terminated
  Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the
• Z-0653-2022 · Dec 3, 2015 · Open, Classified
  Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced usi
• Z-0540-2014 · Nov 22, 2013 · Terminated
  Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infu

…and 1 more.