Merit Medical Systems, Inc. device recall (Cls I)

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B — Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. — Status: Ongoing