Smiths Medical recalls infusion pumps due to software issues

Smiths Medical has recalled CADD-Solis ambulatory infusion pumps due to issues linked to outdated software, according to the FDA. Problems include failures to emit alarms, unresponsive stop and power keys, and unintended exposure of passwords to unauthorized users. Although ICU Medical, which acquired Smiths Medical in a $2.35 billion deal, addressed many of these issues in earlier software updates, one injury has been reported.

ICU Medical’s acquisition has led to challenges, including a warning letter, recalls, and declining sales. The recent recall concerns a wearable infusion pump used in home care and pain management. Smiths Medical identified eight issues with these pumps during a risk evaluation review. The FDA, which recently classified the recall as Class I, reported one injury but no fatalities. Despite improvements in sales for Smiths Medical’s portfolio, significant challenges remain.