Medical, Lab & IT Equipment Benchmarking & Analytics

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Medical, Lab & IT Equipment Benchmarking & Analytics

July 24, 2025

Market Alerts

FDA Alert for Device Issue with Baxter Novum IQ Infusion Pumps

This is to notify you of a recently announced device issue affecting all Baxter’s Novum IQ Large Volume Pumps (#40700BAXUS), as we know that many of our clients currently use Baxter pumps. A letter from Baxter was issued to all affected customers on July 14th, but some have indicated that they did not see this communication.

The issues noted in this alert are not the same as those cited in the Novum IQ product recalls announced by the FDA on June 6th of this year.

This week, the FDA issued an early alert for the following two issues affecting all Novum IQ pumps:

  1. When significantly transitioning (g., doubling) flow rates during use, Novum IQ pumps have a potential risk of under-infusion or, in worst cases, no delivery at all.
  2. When using the pump after improperly loading of the tube into the pump channel, Novum IQ pumps have a potential risk of over-/under-infusion and causing delivery at a faster rate than programmed.

The FDA alert indicates that these issues have resulted in serious patient injury and/or death, as reported by Baxter.

Baxter has provided several recommendations for mitigating risk and ensuring continuity of patient care, all of which can be found within the full FDA warning here. Users are encouraged to audit their existing pump fleet and follow the product instructions as directed.

Miga Solutions will continue to monitor this situation and send additional information as it becomes available.

– The Miga Team

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And get it.

Having the right information saves hospitals time and money on medical equipment lifecycle costs.

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