Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070 Recalled by Merit Medical Systems, Inc. Due to Merit Medical Systems, Inc. announces a voluntary field...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.
Affected Products
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
Quantity: 1,265 total
Why Was This Recalled?
Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report