Novum IQ 40800BAXUSLRecalls & reported problems
Baxter Healthcare Corporation · The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. · Class 2
All models of Novum IQ (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
4 other recalls cover devices cleared under the same FDA submission (K242390); 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
- Aug 11, 2026Class IIOpen, 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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K242390. One submission often covers many models, so check the product and lot details in each record.
- Z-3065-2026 · Aug 11, 2026 · Open, ClassifiedBaxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Z-2333-2025 · Aug 4, 2025 · Open, ClassifiedNovum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
- Z-1964-2025 · May 12, 2025 · Open, ClassifiedBaxter Novum IQ Syringe Pump, product code 40800BAXUS,
- Z-1423-2025 · Mar 3, 2025 · Open, ClassifiedBaxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Other Pump, infusion, enteral devices
- Kangaroo 775100Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL988 reports
- Kangaroo 382400Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL677 reports
- Kangaroo 383400Cardinal Health, Inc. · Pump, Infusion, Enteral1 death659 reports
- Infinity Enteral Feeding Pump INFKIT2Zevex International, Inc. · Pump, Infusion, Enteral2 deaths407 reports
- Infinity Enteral Feeding Pump INFP01Zevex International, Inc. · Pump, Infusion, Enteral1 death207 reports
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
- Kangaroo 775659Cardinal Health, Inc. · PUMP, INFUSION, ENTERAL1 death139 reports
- Perfusor® 8713031UB. Braun Medical Inc. · PUMP, INFUSION, ENTERAL1 recall21 deaths87 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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