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

Recalled May 25, 2016 · FDA recall Z-1672-2016 · Medtronic Navigation

Hazard

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

Units

120

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Medtronic Navigation, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →