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Recall Observatory FDA recall evidence

Device 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.

Z-0244-2023

October 14, 2022

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 91041
Status
Ongoing
Classification
Class II
Quantity
95 units
Official record key
device-enforcement:Z-0244-2023

Official wording

Reason: Due to a defect in the outer pouch sterile seal

Code information: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to a defect in the outer pouch sterile seal