FDA MedWatch - Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

AUDIENCE: Risk Manager, Surgery, Cardiology, Nephrology

ISSUE: 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.

• Recalled Product: Merit 7F Prelude Short Sheath Introducers
• Lot Numbers: H1041469, H1041473, H1036880, H1041464
• Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT
• Manufacturing Dates: November 23, 2016 to November 30, 2016
• Distribution Dates: December 15, 2016 to January 18, 2017
• Devices Recalled in the U.S.:  1,265 units

BACKGROUND: 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.

RECOMMENDATION: On February 16, 2017, Merit Medical Inc. sent an Urgent Product Recall Notice to affected customers. The notice also asked customers 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 response@xxxxxxxxx.
• Return all affected lots in possession to Merit Medical Inc. per the instructions found in the Customer Response Form.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550080.htm

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