A device used to deliver therapeutic or diagnostic intravascular devices or fluids through the skin is being recalled because the introducer tips may detach during use and cause serious and potentially deadly injury. The recall includes Prelude Short Sheath Catheter Introducers, manufactured by Merit Medical Systems, and is classified as a Class 1 recall, the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. 

The recall notice warns that if the introducer tips are used, they may detach and cause arterial injury, hemorrhaging, or other serious problems. The introducer tip material can also enter into the bloodstream causing blood clots, also known as thrombosis.

The recall includes the Prelude Short Sheath Introducer, 7F=SMT, 4cm, reference number PSS-7F-4-038MT, Sterile EO, Merit, lot/serial number H179575. There are 378 devices included in the recall. Merit Medical Systems is advising its customers to immediately discontinue use of any affected product, examine their inventory for the devices, and quarantine all affected products.

Any serious side effects associated with these devices should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch. Questions regarding the products should be directed to Merit Medical Systems at 1-801-316-4932 or 1-800-356-3748, between the hours of 8 a.m. to 5 p.m. mountain standard time,  Monday-Friday.