Defective Novum pumps prompt Baxter to recall certain models, linked to 79 reported injuries and 2 fatalities.
Last updated on June 11, 2025
Originally written by Nick Paul Taylor
The Baxter Novum IQ Large Volume Pump, a key component in Baxter's attempt to expand its share of the infusion pump market, has been linked to safety concerns involving underinfusion, overinfusion, and non-delivery of medications or fluids.
These issues, primarily occurring during transitions from lower to higher flow rates or due to tubing set misloading, have reportedly resulted in at least 79 serious injuries and two deaths, according to reports submitted to the FDA by June 27, 2025.
The Food and Drug Administration (FDA) published an early alert recommending healthcare providers change the IV administration set or use an alternate pump at the earliest safe opportunity. If changing the IV set is not immediately possible, users should manually adjust tubing placement before altering flow rates.
Baxter issued an urgent medical device correction in July 2025 related to these issues in both the U.S. and Canada, reflecting a recall or safety alert. The pump does not currently require a manufacturer return but must be used according to updated instructions.
Underinfusion risks arise due to the possibility of less fluid being delivered than programmed, with extreme cases resulting in no medication delivery at all. Overinfusion and underinfusion can also result from incorrect loading of the IV tubing into the pump channel, leading to infusion rates that differ from those programmed.
Baxter advises users to change the pump and infusion set at a time when a delay in treatment would not harm the patient. Potential adverse effects include cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events.
The company has provided recommendations for healthcare professionals who cannot change the pump without causing an unacceptable delay in infusion. Baxter is also working to increase its share of a market served by rival devices, including BD's Alaris pumps.
While market competition details are not explicitly provided, safety concerns such as these usually affect market dynamics as healthcare providers may switch to alternative products or brands until the safety issues are resolved and confidence is restored.
[1] FDA Notification, Baxter Urgent Medical Device Correction - Novum IQ Large Volume Pump, July 2025, [link] [2] FDA Early Alert, Baxter Novum IQ Large Volume Pump, June 2025, [link] [3] Health Canada Recall Notification, Baxter Novum IQ Large Volume Pump, July 2025, [link] [4] Baxter Press Release, Baxter Initiates Device Correction for Novum IQ Large Volume Pump, June 2025, [link]
- The FDA's early alert suggests healthcare providers should consider changing the IV administration set or using an alternate pump for the Baxter Novum IQ Large Volume Pump, a device linked to safety concerns in healthcare.
- The Baxter Novum IQ Large Volume Pump, a key device in Baxter's medtech ventures, has been associated with underinfusion, overinfusion, and non-delivery of medications or fluids, as indicated by reports to the FDA.
- The Food and Drug Administration (FDA) has published warnings about these issues, recommending users to manually adjust tubing placement before changing flow rates, as a temporary solution when immediately changing the IV set is not possible.
- Baxter, in response, issued an urgent medical device correction in July 2025, reflecting a recall or safety alert, guiding users to adhere to updated instructions.
- AI-driven analytics could be useful in understanding the root causes of these malfunctions and ensuring the safety and efficacy of healthcare and medtech devices like the Novum IQ Large Volume Pump.
- The healthcare and wellness industry closely followed the news of these safety concerns, as incidents like these might prompt hospitals and providers to switch to alternative therapies and treatments.
- Meanwhile, Baxter continues to face competition in the infusion pump market, with companies like BD's Alaris offering rival devices, aiming to capitalize on these safety concerns to expand their market share.
