Device product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Z-1434-2025
Product summary
- Event
- Event 96292
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-1434-2025
Official wording
Reason: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Code information: UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Distribution pattern: International distribution to the country of Japan.
Derived failure modes
-
Unknown
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.