Z-1434-2025Class II

Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D

Name: Z-1434-2025 Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Creator: Merit Medical Systems, Inc.
Published: 2025-01-27
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2025-01-27 / Open, Classified / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D on 2025-01-27. FDA classified it as Class II and gives the reason as "Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1434-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-27
Posted: 2025-03-24
Recalling firm: Merit Medical Systems, Inc.
Product: Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Product code: DYB Introducer, Catheter
Reason for recall: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Questions can be directed to Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
Quantity in commerce: 40
Distribution: International distribution to the country of Japan.
Product codes and lots: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1434-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1434-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-24

Product code DYB

K173750Class IIPrelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc. / cleared 2018-02-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)