Dive Brief:

• Smiths Medical has recalled infusion pumps over multiple problems linked to old software, the Food and Drug Administration said Tuesday.
• The problems affect CADD-Solis ambulatory infusion pumps, which may fail to emit alarms, have unresponsive stop and power keys and reveal passwords to people with access to certain files.
• The ICU Medical subsidiary said it corrected many of the issues in earlier software updates when it sent an urgent notice in February and the devices are staying on the market. The FDA said there has been one reported injury.

Dive Insight:

ICU Medical acquired CADD-Solis, which is used in home care and pain management, in its $2.35 billion purchase of Smiths Medical. The portfolio has caused ICU Medical problems, with a warning letter, recalls and falling sales since the takeover closed early in 2022.

Syringe pumps were a focus of the earlier problems. The latest issue affects a pump that patients can wear on a strap to receive infusions as they move around their home or inpatient facility.

Smiths Medical identified eight issues with the ambulatory pumps in a historical review of the risk evaluations conducted during its software development process.

“Our historical review determined that some of the risk evaluations conducted in the past did not fully account for all the risks associated with an issue,” the company said in its urgent medical device correction. “After reevaluating the patient risk, Smiths Medical determined that the issues identified below were associated with sufficient patient risk that it is necessary to notify you, even if the remediation for an issue was available in previous software versions.”

The correction, sent in February, said Smiths Medical had not received any reports of serious injuries or deaths related to the issue. Tuesday's FDA notice, which it published days after categorizing the recall as Class I, said there has been one reported injury and no reports of death.

Speaking on an ICU Medical earnings call Wednesday, an analyst said some negatives related to Smiths Medical “feel like they’re turning positive.” CEO Vivek Jain gave a cautious response while noting the improvement. 

“[For] the Smiths portfolio in aggregate, this was the best quarter of sales since sort of the back order catch-up on the Smiths portfolio, but there's still a long way to go,” Jain said. “So, I appreciate the comment, but there's still areas for improvement.”