March 31, 2017 — The U.S. Food and Drug Administration (FDA) announced it has initiated a Class I recall of the Merit Prelude Short Sheath Introducer, warning that a manufacturing defect may cause the tip to separate from the sheath during the separation procedure. The agency said that 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 the veins and arteries. The device is also used during temporary hemodialysis, a treatment for kidney failure.
Lot numbers affected by the recall include H1041469, H1041473, H1036880 and H1041464; catalog numbers include K15-00070, K15-00170, PSS-7F-4-035MT and PSS-7F-4MT. The recall impacts products manufactured from Nov. 23-30, 2016, and distributed between Dec. 15, 2016 and Jan. 18, 2017. The FDA said a total of 1,265 units are impacted by the recall.
Merit Medical sent an Urgent Product Recall Notice to affected customers on Feb. 16, 2017, asking them to:
- Ensure appropriate staff is aware of the notice;
- Quarantine any affected products and discontinue use;
- Complete the Customer Response Form attached to the notice and return by email at [email protected]; and
- Return all affected lots in possession to Merit Medical Inc. per the instructions found in the Customer Response Form.
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.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.
For more information: www.merit.com; www.fda.gov/Safety/MedWatch/default.htm
