FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Recall number
- Z-1434-2025
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Status
- Open, Classified
- Initiated
- 2025-01-27
- Posted
- 2025-03-24
- Terminated
- not on file
- Reason
- Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Root cause
- Packaging process control
- Action
- On 1/27/2025, recall notices were sent to customers asking them to do the following: 1) Quarantine, and discontinue use and distribution of affected devices. 2) Return all affected lots in your possession to the recalling firm. 3) Ensure that applicable personnel within your organization are made aware of this field action. 4) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Questions can be directed to Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
- Quantity
- 40
- Distribution
- International distribution to the country of Japan.
- Lot, serial or model codes
- UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
- 510(k) numbers
- ["K173750"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28