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Sheath Device Introducer Recall, Sheath Tip Separation During Use


On March 31, 2017, Merit Medical Systems Inc. recalled the Merit 7F Prelude Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the 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 Merit Prelude Short Sheath Introducer is used to guide the placement of catheters, grafts, and other medical devices into veins and arteries. The device is also used during temporary hemodialysis, a treatment for kidney failure.

 

This recall affects 1,265 units in the United States. Recalled products are from Lot Numbers H1041469, H1041473, H1036880, or H1041464. Recalled products have Catalog Numbers K15-00070, K15-00170, PSS-7F-4-035MT, or PSS-7F-4MT. Recalled products were manufactured between November 23, 2016, and November 30, 2016. Recalled products were distributed between December 15, 2016, and January 18, 2017.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the FDA Safety Alert

 

See the Recall

 

 

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