FDA Device recall Z-1434-2025
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- FDA Device
- Class II
- ongoing
- Published 2025-04-02
On 2025-04-02 the FDA classified a Class II recall of Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D by Merit Medical Systems, citing hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1434-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-27 |
| Published | 2025-04-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | n/a |
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Reason
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Identifiers
| code_info | UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1434-2025%22
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