The FDA has upgraded the previously announced recall of Merit Medical Systems’ Prelude short sheath introducers to a Class I because the introducer tips may detach during use causing arterial injury, hemorrhaging or other serious events, while introducer tip material may enter into the bloodstream causing blood clots.
The Prelude short sheath introducer (7F-SMT, 4 cm) is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures. The recall affects one lot of the product (number H179575), which includes 378 devices.
The South Jordan, Utah-based company notified sales representatives and authorized distributors on Dec. 17, 2010, by email, phone and fax to immediately contact customers to identify, quarantine and return all unused inventory. In addition, distributors were instructed to extend the recall to any of their customers who may have received the affected products.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.