Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Summary
The FDA issued a Class II for Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D by Merit Medical Systems, Inc.. Reason: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Details
Source
Device Recall
External ID
Z-1434-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Lot/Code Info: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Quantity Affected: 40
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-27
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 216 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merit Medical Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Merit Medical Systems, Inc. have FDA actions?
Merit Medical Systems, Inc. has 117 FDA actions in our database, including 95 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1434-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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