MedfusionRecalls & reported problems across all models

We found 16 models of Medfusion by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 13,114 adverse event reports in the FDA's MAUDE database, received between Feb 12, 2016 and Sep 30, 2026 — classified as 3 deaths, 17 injuries, 13,094 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (5,141 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Medfusion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1541-2024 · Root cause: Process control · names 7 of these models · Recall details · FDA record ↗

2. 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 · names 5 of these models · Recall details · FDA record ↗

3. 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-0079-2024 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗

4. 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-0078-2024 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

5. 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 Medfusion problems

Medfusion models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Medfusion 4000-0106-01

  ACCESSORIES, PUMP, INFUSION
  2 recalls4,390 reports
• Medfusion 4000-0105-51

  ACCESSORIES, PUMP, INFUSION
  2 recalls2,882 reports
• Medfusion 3500-0600-01

  Pump, infusion
  2 recalls2,041 reports
• Medfusion 3500-500

  Pump, infusion
  2 recalls2 deaths1,884 reports
• Medfusion 4000-0101-51

  Pump, infusion
  2 recalls1 death1,795 reports
• Medfusion 3500-0600-82

  Pump, infusion
  2 recalls89 reports
• MEDFUSION 4000-0106-00

  ACCESSORIES, PUMP, INFUSION
  2 recalls10 reports
• Medfusion 3500-0600-00

  ACCESSORIES, PUMP, INFUSION
  2 recalls9 reports
• MEDFUSION 4000-0106-231

  Pump, infusion
  2 recalls5 reports
• Medfusion 3500-0600-51

  ACCESSORIES, PUMP, INFUSION
  2 recalls2 reports
• Medfusion 4000-0105-249

  Pump, infusion
  2 recalls1 report
• Medfusion 4000-0105-78

  ACCESSORIES, PUMP, INFUSION
  2 recalls0 reports
• MEDFUSION 4000-0107-01

  Pump, infusion
  1 recall3 reports
• Medfusion 22-1000-51

  ACCESSORIES, PUMP, INFUSION
  1 report
• Medfusion 3000CAL

  Pump, infusion
  1 report
• Medfusion 67-2477-0600-01

  Pump, infusion
  1 report

Recent Medfusion adverse event reports

The 15 most recent reports across all models, 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 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 29, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933640 ↗
• MalfunctionSep 28, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923744 ↗
• 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, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903257 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903126 ↗
• 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 ↗

Other Icu Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Medex98 models · 774 reports · 23 recalls
• Plum26 models · 1,358 reports · 6 recalls