Devices

Device Recall 7F Prelude Short Sheath Introducer

Model / Serial
Lot Numbers: H1041469, H1041473, H1036880, H1041464.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
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.
Manufacturer
Merit Medical Systems, Inc.
1 Event
- Recall of Device Recall 7F Prelude Short Sheath Introducer

Manufacturer

Merit Medical Systems, Inc.

Manufacturer Address
Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
Manufacturer Parent Company (2017)
Merit Medical Systems Inc.
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)