Class I Recall Issued Against Manufacturer of Prelude Short Sheath
The Prelude Short Sheath is a medical device used to guide catheters into the body to treat kidney disease, thrombosis and other conditions that require access to arteries and veins. It has recently been recalled by the U.S. Food and Drug Administration.
The FDA said Merit Medical’s Prelude Short Sheath could cause serious injuries or death if the tip of the sheath separates from the shaft and ends up in a patient’s bloodstream.
“This may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death,” the agency said in a March 31, 2017 safety notice.
Class I Recall Issued for the Prelude Short Sheath
The Class I recall – the most serious of the FDA’s three classes of recalls that denote the danger level of a particular product – includes a requirement that Merit Medical’s customers be made aware of the safety notice, quarantine the affected product and return them to the manufacturer. The affected product is the Merit 7F Prelude Short Sheath Introducer with the following lot numbers: H1041469, H1041473, H1036880 and H1041464. It was produced between Nov. 23 and 30, 2016 and distributed from Dec. 15, 2016 to Jan. 18, 2017. The recall totals 1,265 products.
The recall further instructs customers to call Merit Medical’s service line at (801) 208-4381 with questions, and it urges medical professionals to report adverse events to FDA MedWatch.
This isn’t the first time the Prelude Short Sheath has been on the recall list. In an FDA Enforcement Report published June 17, 2009, the product is listed, citing the reason for the measure as “External tubing may separate during use, allowing blood loss.”