FDA recall Z-1434-2025

Merit Medical Systems, Inc. · Class II · device

Product

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.

Distribution

International distribution to the country of Japan.

Key facts

Status: Ongoing
Initiation date: 2025-01-27
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1434-2025