Medtronic—Visualase Cooled Laser Applicator System Tubing Sets: Luer Connector and Drip-Chamber Assemblies May Be Incorrect; May Have Excessive Adhesive, Potentially Causing Tube Occlusion
July 17, 2019 | Strategic Insights for Health System
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In a July 8, 2019, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Medtronic states that the above sets may have an incorrect Luer connector assembly, an incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion. Medtronic also states that in accordance with the instructions for use (IFU) and software confirmation messages, the user must verify appropriate saline flow and return before delivery of laser energy. These problems could result in disruption or prevention of saline flow. Medtronic further states that it has received no reports of patient injury related to this problem; however, the firm has received reports of short-term delays of procedure. No Visualase procedures have been cancelled or aborted because of this problem. The manufacturer has not confirmed the...