Dive Brief:
- Infutronix’s recall of Nimbus infusion pumps has been linked to thousands of complaints and reports of six injuries and one death, the Food and Drug Administration said Thursday.
- The action, which the FDA categorized as a Class I recall, affects more than 52,000 drug delivery pumps and administration sets. Infutronix began the recall in February and recently told customers it would pull the devices off the market and stop supporting them after June 20.
- The latest update adds information on the nearly 3,700 complaints about the devices. The complaints include reports of six serious injuries and one death.
Dive Insight:
Healthcare professionals use Infutronix’s Nimbus infusion pump systems and sets, which are also sold under the Halo brand, to deliver medicines and fluids to patients. The devices can infuse liquids under or through the skin, in the space between nerves or into blood vessels. Sometimes, patients use the pumps to control the delivery of their own pain medicines.
The recall affects more than 52,000 devices distributed between 2015 and 2024. Across those years, users sent in reports of problems such as battery failures, blockages and drug leakage.
The FDA outlined the potential for harm in a recall notice posted on Thursday. Leaking pumps could cause infection from microbial contamination because they lack a sterile barrier. A blockage could result in patients receiving too little of a drug or fluid, leading to high blood pressure, dehydration and electrolyte imbalance. The faults could cause seizures, shock, organ failure and death.
The agency indicated the severity of the risks when it added the recall to its database in March.
Infutronix has stopped shipping Nimbus pumps but is continuing to provide the administration sets up to June 20. Beyond that, the company will stop supporting pumps and administration sets. Infutronix is withdrawing the devices and their support because the need for redesign may require new premarket notification and clearance from the FDA.
