CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Prelude Ideal 4 F Hydrophilic Sheath Introducer recalled

Merit Medical Systems is recalling Prelude Ideal 4 F Hydrophilic Sheath Introducer. The recall was initiated on 27 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

Quantity recalled40

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1434-2025
FDA event ID: 96292
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jan 2025
FDA classified: 24 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

27 Jan 2025	Recall initiated by company
24 Mar 2025	Classified by FDA	+56 days
2 Apr 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

International distribution to the country of Japan.

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24

Where was it sold?

International distribution to the country of Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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