Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER Recalled by Medtronic Navigation, Inc. Due to Due to a defect in the outer pouch...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc. directly.
Affected Products
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.
Quantity: 95 units
Why Was This Recalled?
Due to a defect in the outer pouch sterile seal
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report