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). The VCLAS system consists Recalled by Medtronic Navigation, Inc. Due to Potential for the Visualase Cooled Laser Applicator System...
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). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
Quantity: 120
Why Was This Recalled?
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Where Was This Sold?
This product was distributed to 1 state: VA
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