BioFlo Dialysis Catheter With Endexo Technology

Issue

Merit Medical Systems, Inc. (Merit) is conducting a voluntary recall of the Merit 16F Dual-valved Splittable Sheath Introducer due to a design defect. Specifically, the sheath introducer may not split as intended. This sheath introducer is used in several Merit finished devices (e.g. BioFlo DuraMax catheter). Merit has received customer complaints related to this issue, some of which involve patient injury. Failure of the sheath introducer to split as intended may result in hemorrhage, foreign bodies, and procedure delay. Merit is requesting customers to immediately discontinue the use of the 16F dual-valved splittable sheath introducer and destroy the sheath introducer at point of use. The other products included with the sheath introducer may continue to be used.