FDA: Class I recall of Merit Medical’s sheath introducer

Editor's Note

The Food and Drug Administration (FDA) on March 31 labeled Merit Medical Systems' (South Jordan, Utah) recall of the Prelude Short Sheath Introducer as Class I, the most serious.

The recall was issued because of a manufacturing defect that may cause the tip to separate from the sheath during the insertion procedure. This may result in prolonged procedure times, additional surgery to remove the tip, blood clots, internal tears and perforations of arteries or veins, excessive bleeding, and death.

Manufacturing dates of the device are November 23, 2016 to November 30, 2016. Distribution dates are December 15, 2016 to January 18, 2017.

Tip could enter the patient's bloodstream, resulting 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.