FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 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.
- Recall number
- Z-1497-2017
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-02-16
- Posted
- 2017-03-24
- Terminated
- 2017-08-08
- Reason
- 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.
- Root cause
- Process control
- Action
- Consignees notified on 2/16/17 to immediately stop using or distributing the affected lots and return them to Merit. For any questions, please contact your Merit Sales Representative or Merit Customer Service at 801.208.4381.
- Quantity
- 1,265 total
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Lot, serial or model codes
- Lot Numbers: H1041469, H1041473, H1036880, H1041464.
- 510(k) numbers
- ["K082063"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28