Novum IQRecalls & reported problems across all models

We found 3 models of Novum IQ by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 1,540 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2023 and Sep 25, 2026 — classified as 4 deaths, 135 injuries, 1,401 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (397 reports).

7 FDA recall records name at least one of these models by its device identifier, 7 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

Novum IQ 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. Aug 11, 2026Open, Classified

   A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

   Z-3066-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Aug 11, 2026Open, Classified

   A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

   Z-3065-2026 · Root cause: Software design · Recall details · FDA record ↗

3. Aug 4, 2025Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

   Z-2333-2025 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

4. Aug 4, 2025Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

   Z-2332-2025 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

5. Jul 14, 2025Open, Classified

   Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

   Z-2173-2025 · Root cause: Device Design · Recall details · FDA record ↗

6. May 12, 2025Open, Classified

   Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

   Z-1964-2025 · Root cause: Device Design · Recall details · FDA record ↗

7. Mar 3, 2025Open, Classified

   Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

   Z-1423-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Novum IQ problems

Novum IQ models

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

• Novum IQ 40700BAXUS

  Pump, infusion
  2 recalls4 deaths1,192 reports
• Novum IQ 40800BAXUS

  Pump, infusion
  4 recalls348 reports
• Novum IQ 40800BAXUSL

  Pump, infusion, enteral
  1 recall0 reports

Recent Novum IQ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Connection Problem

  It was reported that an unspecified quantity of Novum IQ Syringe Pumps had connection concerns when used with 35 mL non-Baxter ENFit syringes. Similar concerns were reported with another type of non-Baxter ENFit syringe. This occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897292 ↗
• MalfunctionSep 24, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891198 ↗
• MalfunctionSep 24, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890976 ↗
• InjurySep 22, 2026Filling Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50854186 ↗
• MalfunctionSep 22, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849376 ↗
• MalfunctionSep 21, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849271 ↗
• MalfunctionSep 18, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824227 ↗
• MalfunctionSep 18, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821442 ↗
• MalfunctionSep 16, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792350 ↗
• MalfunctionSep 16, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787220 ↗
• MalfunctionSep 8, 2026False Alarm; Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678768 ↗
• MalfunctionSep 7, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658554 ↗
• MalfunctionSep 1, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50546052 ↗
• MalfunctionAug 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505987 ↗
• MalfunctionAug 26, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459555 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• MiniCap3 models · 3,423 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls