Visualase Cooled Laser Applicator System recalled over fire hazard

Recall date

May 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF…

Recall number

Z-1672-2016

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.

Why it was recalled

Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.