Prelude IDEAL Sheath Introducer (Merit) – incorrect dilator (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Products Sold
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Merit Medical Systems, Inc. is recalling Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D due to Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026