FDA-Device2017-10-25Class II
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Medtronic Navigation, Inc.
Hazard
The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
Sold states
US nationwide distribution.
Affected count
423 devices
Manufactured in
826 Coal Creek Cir, Louisville, CO, United States
Products
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2018Don't want to check this manually?
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