The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Merit Prelude® Short Sheath Introducer is used to guide the placement of catheters, grafts, and other medical devices into the veins and arteries. The device is also used during temporary hemodialysis, a treatment for kidney failure.
Reason for Recall
Merit Medical Systems Inc. is recalling the 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.
Who May be Affected
What to Do
On February 16, 2017, Merit Medical Inc. sent an Urgent Product Recall Notice to affected customers. The notice also asked customers to:
Customers are instructed to contact their Merit Sales Representative or Merit Customer Service by telephone at 801.208.4381 with any questions related to this recall.
Date Recall Initiated
February 16, 2017