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Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagul
Recalled November 23, 2022 · FDA recall Z-0244-2023 · Medtronic Navigation
Hazard
Due to a defect in the outer pouch sterile seal · FDA Class II
Units
95 units
Sold at
U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.
Description
Due to a defect in the outer pouch sterile seal
Product
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →