FDA DeviceClass INotable

FDA Recall: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

Date: 2026-04-01
Brand: Merit Medical Systems, Inc.
Category: Medical Device
FDA Class: Class I

Description

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

Hazard

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.

Remedy

368,264

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