Medfusion 4000-0106-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4,390 adverse event reports that list this exact device (DI 15019517069624), received between Nov 9, 2017 and Sep 30, 2026 — classified as 4 injuries, 4,386 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1,732 reports).

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

14 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-1541-2024 · 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-0079-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,390 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Noise, Audible; Inadequate Lubrication

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951801 ↗
• MalfunctionSep 30, 2026Pumping Problem

  It was reported that, during inspection of the returned Medfusion 4000 Syringe Infusion Pump, a Travel Course Error was confirmed through review of the alarm history. There was no patient involvement; however, no patient harm or adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946144 ↗
• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939667 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904695 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903493 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903338 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902586 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  It was reported that the Medfusion 4000 Syringe Infusion Pump experienced an ACU watchdog failure and a primary audible alarm background test failure during self-test. This issue will interrupt the therapy if it recurs during patient use. There was no patient involvement, patient harm, or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897860 ↗
• MalfunctionSep 25, 2026Pumping Problem

  It was reported that the Medfusion 4000 Syringe Infusion Pump experienced an invalid syringe alarm. The pump did not recognize BD syringes during testing. If this high-priority error were to recur during an infusion, it could result in an interruption of therapy. There was no patient involvement and no patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897194 ↗
• MalfunctionSep 24, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886606 ↗
• MalfunctionSep 24, 2026Failure to Infuse

  It was reported that during power on, the Medfusion 4000 Syringe pump had a problem with the travel reverse error check clutch and plunger lever. There was no patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886259 ↗
• MalfunctionSep 22, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859338 ↗
• MalfunctionSep 22, 2026Failure to Infuse

  It was reported that the Medfusion 4000 Syringe Infusion Pump displayed blank screen with constant alarm. There was no patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855255 ↗
• MalfunctionSep 21, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848347 ↗
• MalfunctionSep 18, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829382 ↗
• MalfunctionSep 18, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828422 ↗
• MalfunctionSep 18, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828181 ↗
• MalfunctionSep 18, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828108 ↗
• MalfunctionSep 18, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823497 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806223 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  It was reported that the pump exhibited an Alarm control unit (ACU) watch dog failure. This is a high-priority alarm that prevents the device from operating and interrupts therapy. There was no patient involvement and no harm/adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805766 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  It was reported that the pump has motor speed error, a high-priority alarm which if recur during use can interrupt therapy. There was reported unknown patient involvement and reported unknown patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803631 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  It was reported that the O-ring on the Plunger was falling off and was giving a "Check syringe Plunger Sensor" Error. The event occurred during preventative maintenance upon start up. There was no patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802454 ↗
• MalfunctionSep 16, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794113 ↗
• MalfunctionSep 16, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792835 ↗

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-1543-2024 · Dec 19, 2023 · Open, Classified
  Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
• Z-0864-2024 · Dec 19, 2023 · Open, Classified
  smiths medical Medfusion Model 4000 syringe pump
• 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
• Z-2107-2012 · Feb 14, 2012 · Terminated
  Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78