FDA-Device2025-04-02Class II
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hazard
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Sold states
International distribution to the country of Japan.
Affected count
40
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1434-2025More Merit Medical Systems, Inc. recalls
- FDA-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
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