Z-1497-2017Class I

7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc...

Name: Z-1497-2017 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc...
Creator: Merit Medical Systems, Inc.
Published: 2017-02-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2017-02-16 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2017-02-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1497-2017
Classification: Class I
Status: Terminated
Initiated: 2017-02-16
Posted: 2017-03-24
Terminated: 2017-08-08
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,265 total
Distribution: Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
Product codes and lots: Lot Numbers: H1041469, H1041473, H1036880, H1041464.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1497-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1497-2017	Class I	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

Product code DYB

K082063Class IIPrelude Short Sheath IntroducerMerit Medical Systems, Inc. / cleared 2008-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)