Class II

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

Merit Medical Systems, Inc. · January 27, 2025

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.

Quantity Affected

40

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1434-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Merit Medical Systems, Inc. Medical Device Recall: Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | SafeCheck