Dive Brief:
- BD has written to users of its Alaris pump modules about a risk associated with two complaints of serious injury.
- The Food and Drug Administration, which shared details of the letter Friday, has categorized the correction as a Class I recall because of the potential for serious injury or death.
- BD paid a $175 million civil penalty last year to settle charges that it misled investors about problems with its Alaris infusion devices and in September recalled pumps with variable performance.
Dive Insight:
BD sent a letter to Alaris pump module users on Oct. 17. The company told customers to immediately remove from use any devices they drop or severely jar. Before reusing a pump, healthcare professionals should have the device thoroughly tested and inspected by qualified service personnel in accordance with the instructions for use.
The advice reflected two complaints about dropped or severely jarred devices. A BD spokesperson said the company received the complaints between January 2016 and June 2025. The two reports described serious injuries requiring medical intervention that resulted in a return to hemodynamic stability, the spokesperson wrote in an email.
Dropping or severely jarring an Alaris pump module may damage the device’s bezel assembly. Because the assembly provides the mechanical foundation for critical pumping components, damage can lead to under-infusion, over-infusion, unregulated flow or calibration failures. Infusion errors can cause serious injury or death, depending on factors such as the drug being delivered and the patient’s condition.
While the user manual recommends inspecting pumps for visual damage, bezel assembly problems caused by drops and severe jarring may not be apparent or readily visible. The potential for hidden damage informs the recommendation to remove any dropped or severely jarred devices from use.
Software problems and regulatory compliance issues led BD to stop shipping Alaris pumps in 2020. BD received FDA clearance for an updated version of the Alaris system in 2023. While BD has continued to flag issues with discontinued Alaris devices this year, the company recently reported record quarterly installations of its current pumps. BD CEO Thomas Polen told investors on a November earnings call that the company achieved “several new competitive wins” in the pump market.
“We’re really pleased with how the team has executed,” Polen said. “They’ve done an outstanding job remediating ahead of commitment on a massive scale. We’ve locked in our installed base and leadership for many years to come, and that’s really allowing us to pivot heavily to share gains and growth opportunities.”
The high level of pump installations in BD’s 2025 financial year led the company to warn that Alaris will suppress sales growth in the coming year. Polen predicted Alaris will have “a very strong year” in 2026 and continue to win share, but warned that the comparison to 2025 will create “a natural headwind.”
