Recall Z-1434-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-1434-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-27

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-01-27. It names one FDA 510(k) clearance: K173750. Product: Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D. Reason: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-27
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K173750 — Prelude IDeal Hydrophilic Sheath IntroducerMerit Medical Systems, Inc.·cleared 2018-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

Data sourced from openFDA. This site is unofficial and independent of the FDA.