Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS…

Recall date

July 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1905-2020

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK

Why it was recalled

The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter