Medfusion 3500-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,884 adverse event reports that list this exact device (DI 10610586032318), received between Feb 12, 2016 and Sep 25, 2026 — classified as 2 deaths, 2 injuries, 1,880 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (672 reports).

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

19 other recalls cover devices cleared under the same FDA submission (K040899); 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 16, 2026.

Recalls naming this device

1. Dec 19, 2023Open, 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, 2023Open, 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-0076-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,884 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903257 ↗
• MalfunctionAug 14, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50262088 ↗
• MalfunctionJun 5, 2026Failure to Infuse

  IT WAS REPORTED THAT DURING TESTING WHEN DOING THE PLUNGER TRAVEL TEST IT WAS GIVING FORCE SENSOR BACKGROUND TEST ALARM. THERE WERE NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417392 ↗
• MalfunctionFeb 20, 2026Failure to Infuse

  THE CUSTOMER RETURNED THE PRODUCT FOR ERROR MESSAGE- PRIMARY AUDIBLE ALARM BACKGROUND TEST AND THAT IT NEEDED AN UPGRADE TO THE LATEST SOFTWARE VERSION. DURING DEVICE EVALUATION, THE PRIMARY AUDIBLE ALARM BACKGROUND TEST ALARM WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400874 ↗
• MalfunctionJun 30, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A MOTOR RATE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358989 ↗
• MalfunctionMar 26, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN ACU WATCHDOG FAILURE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701827 ↗
• MalfunctionMar 26, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP EXHIBITED TRAVEL COURSE ERROR AND CHECK CLUTCH/PLUNGER LEVER. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697134 ↗
• MalfunctionMar 19, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP WAS NOT CALIBRATED SUCCESSFULLY. DURING PHYSICAL INSPECTION, IT WAS FOUND THAT THERE WAS A CHECK CLUTCH ALARM. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644273 ↗
• MalfunctionFeb 5, 2025Misassembly During Maintenance/Repair; Misassembly During Maintenance/Repair

  IT WAS REPORTED THAT THE DEVICE'S CALIBRATION SLUG DOES NOT LINE UP PROPERLY WITH THE FORCE SENSOR. PER REPORTER IT NEEDS TO BE SLIGHTLY LIFTED TO MAKE CONTACT. THE POSITION READINGS ARE AFFECTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312965 ↗
• MalfunctionJan 27, 2025Circuit Failure; Failure to Sense; Circuit Failure; Failure to Sense

  IT WAS REPORTED THAT THERE WAS A MOTOR RATE ERROR THAT WAS STILL PRESENT ON THE PUMP. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246251 ↗
• MalfunctionJan 13, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A CHECK/CLUTCH PLUNGER LEVEL ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143356 ↗
• MalfunctionJan 3, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DEVICE'S LEFT AND RIGHT FLIPPER WERE GETTING STUCK WHEN TRYING TO OPEN AND SHOWS AN ERROR ¿SYSTEM FAILURE: FORCE SENSOR TEST¿. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068438 ↗
• MalfunctionDec 30, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THERE IS A CLICKING SOUND WHEN GEARS TEST. "CHECK CLUTCH PLUNGER LEVER". NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21040115 ↗
• MalfunctionDec 27, 2024Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER RETURNED PRODUCT FOR SUPER CAPACITOR ERROR; PHYSICAL INSPECTION FOUND A FORCE SENSOR ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029370 ↗
• MalfunctionDec 27, 2024Failure to Infuse; Naturally Worn; Failure to Infuse; Naturally Worn

  IT WAS REPORTED THAT THE PUMP EXHIBITED A CHECK CLUTCH, PLUNGER LEVER ALARM DURING OCCLUSION TEST. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026570 ↗
• MalfunctionDec 12, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE SYRINGE ARM GASKET IS OFF OR MISSING. THERE WAS NO PHYSICAL DAMAGED AND DEVICE WAS NOT DROPPED. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE PROCESS. THERE WAS NO DELAY OF THERAPY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918636 ↗
• MalfunctionDec 11, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A MOTOR RATE ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908548 ↗
• MalfunctionDec 10, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE SYRINGE ARM GASKET IS OFF OR MISSING. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE PROCESS. THERE WAS NO PATIENT INVOLVEMENT. DEVICE EVALUATION PRODUCED A MOTOR RATE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898055 ↗
• MalfunctionDec 9, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE NEEDS THE SOFTWARE PATCH AND IS RUNNING LOUD AND GIVING PLUNGER AND CLUTCH ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878323 ↗
• MalfunctionDec 5, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP SHOWED TWO ERRORS; 'CLUTCH/PLUNGER LEVEL" .9840ML; AND "SYSTEM FAILURE-PRIMARY AUDIBLE ALARM." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857562 ↗
• MalfunctionDec 2, 2024Premature Discharge of Battery; Improper Flow or Infusion; Premature Discharge of Battery; Improper Flow or Infusion

  IT WAS REPORTED THAT AFTER THE PUMP WAS UPDATED TO V6.03, THERE WAS A BATTERY DEPLETION ISSUE AND A PRIMARY AUDIBLE ALARM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818730 ↗
• MalfunctionNov 25, 2024Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE DEVICE 'APPEARS TO BE IN A BOOT LOOP. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774599 ↗
• MalfunctionNov 21, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE FAILED THE OCCLUSION TEST ON THE PREVENTATIVE MAINTENANCE (PM). PER REPORTER THE DEVICE KEPT GIVING THE CHECK CLUTCH / PLUNGER LEVER ERROR. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748308 ↗
• MalfunctionNov 20, 2024Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  IT WAS REPORTED THAT THE MOTOR RATE ERROR DURING OCCLUSION TEST. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740237 ↗
• MalfunctionNov 20, 2024Failure to Infuse; Naturally Worn; Failure to Infuse; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A MOTOR RATE ERROR DURING OCCLUSION TEST. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040899. One submission often covers many models, so check the product and lot details in each record.

• Z-1542-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
• Z-0863-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 3500 Syringe pump
• Z-0078-2024 · Aug 16, 2023 · Open, Classified
  Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
• Z-0077-2024 · Aug 16, 2023 · Open, Classified
  Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
• Z-1272-2022 · Apr 18, 2022 · Open, Classified
  Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC,
• 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-2662-2018 · Apr 13, 2018 · Terminated
  Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
• Z-1136-2018 · Nov 13, 2017 · Terminated
  Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion r
• Z-1135-2018 · Nov 13, 2017 · Terminated
  Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion r
• Z-0314-2018 · Aug 22, 2017 · Terminated
  Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In t
• 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-1206-2012 · Jan 2, 2012 · Terminated
  Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, dru
• Z-2121-2010 · Jun 22, 2010 · Terminated
  MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas
• Z-0996-2013 · May 14, 2010 · Terminated
  Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion r

…and 4 more.