Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk

Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.

The FDA classified this recall as the most serious type, warning that the catheters could cause infection, embolism, thrombosis, serious injury, or death if they continue to be used.

Customers are instructed to check their inventories, quarantine the listed models, and destroy the affected lots after recall actions are complete. Affected models include several St. Jude Medical, Abbott Inquiry, Biosense Webster, and ACUSON catheters.

The recall adds new product lots to the previously published list, and Medline has sent a letter to customers advising removal of the devices from use or sale.