The FDA today released data on a recall of Merit Medical‘s (NSDQ:MMSI) Prelude short sheath introducer over issues with the tip separating during the insertion process, and labeled the recall a Class 1.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
Merit Medical’s Prelude short sheath introducer is used to guide the placement of catheters, grafts and other devices into the veins and arteries, and can be used during temporary hemodialysis.
The company is recalling the device over manufacturing defects which may cause the tip to separate from the sheath during the insertion procedure.
A split tip could enter the patient’s bloodstream and prolong procedure times and require additional surgeries, the FDA said. The issue could also cause blood clots, internal tears and perforations of the arteries or veins, excessive bleeding and possibly death.
The recall affects 1,265 units in the US with lot numbers H1041469, H1041473, H1036880 and H1041464 with catalog numbers K15-00070, K15-00170, PSS-7F-4-035MT and PSS-7F-4MT, manufactured between Nov. 23, 2016 and Nov. 30, 2016 and distributed between Dec. 15, 2016 and Jan 18, 2017, according to the FDA release.
Merit Medical began notifying affected customers on Feb. 16, instructing them to quarantine and return affected products.
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