Device 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.
Z-1497-2017
Product summary
- Event
- Event 76596
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,265 total
- Official record key
device-enforcement:Z-1497-2017
Official wording
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.
Code information: Lot Numbers: H1041469, H1041473, H1036880, H1041464.
Distribution pattern: Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Derived failure modes
-
Unknown
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.