Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
FDA device recall Z-1434-2025 · posted 2025-03-24 · Open, Classified
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 40
- Distribution
- International distribution to the country of Japan.
- Date initiated
- 2025-01-27
- Date posted
- 2025-03-24
- Location
- South Jordan, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Prelude IDeal Hydrophilic Sheath Introducer (K173750) | Merit Medical Systems, Inc. | 2018-02-15 |