According to the FDA, the agency upgraded a recall of a catheter introducer to Class I, the agency’s most serious type of recall. The recall required an upgrade as the catheter tip might detach and cause thrombosis. The FDA classifies recalls as Class I only if product’s use is likely to cause serious personal injury or death.
A Merit Prelude Short Sheath Catheter Introducer 7F-SMT, 4 centimeter tip may cause arterial injury, hemorrhaging and other serious injuries after detaching, the FDA’s statement warns.
The recall includes 378 devices of product number H179575 with reference number PSS-7F-4-038MT. This type of catheter introducer provides access of other medical devices into veins or arteries while causing the bleeding process to stop.
Merit Medical Systems, makers of the catheter introducer, initiated the recall in 2010 by requesting its distributors and representative contact customers, quarantine identified devices and return unused products. Merit Medical Systems warned its customers to stop using the defective device, immediately.