Merit Medical Systems, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1497-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: February 16, 2017

Date Posted: April 5, 2017

Recall Number: Z-1497-2017

Event ID: 76596

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1,265 total

Code Information:

Lot Numbers: H1041469, H1041473, H1036880, H1041464.

Distribution Pattern:

Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.

Voluntary or Mandated:

Voluntary: Firm initiated