Merit Medical Systems recalled its Merit 7F Prelude short sheath introducer, which is used to guide the placement of catheters, grafts and other medical devices into the veins and arteries. It is also used during temporary hemodialysis.
The FDA announced the recall on March 31.
The recall affects 1,265 devices in the U.S. manufactured from Nov. 23 to Nov. 30, 2016 and distributed from Dec. 15, 2016, to Jan. 18, 2017.
The agency said a manufacturing defect with the Prelude could cause the tip to separate from the sheath and enter the patient’s blood stream. If that occurs, it could lead to longer procedure times, additional surgery to remove the tip, blood clots, internal tears and perforation to arteries or veins, excessive bleeding and death.
The FDA classified the action a Class I recall, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Merit Medical sent an urgent product recall notice to affected customers on Feb. 16. The affected lot numbers are H1041469, H1041473, H1036880 and H1041464.
On March 27, Merit Medical announced the company expected to earn net proceeds of $136.5 million in a public offering of common stock. The company plans on using the money to repay debt under an existing credit facility.
In February, Merit Medical paid $48 million to acquire interventional cardiology products from Argon Medical Devices and Catheter Connections.