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.
FDA Recall Z-1672-2016 · Posted 2016-05-16
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Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2016-05-09
Date Terminated2016-12-19
Product Quantity120
Reason for Recall
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Firm Action
Medtronic will be sending a Medical Device Safety Notification letter FedEx on May 18, 2016. Each customer will be asked to complete and return a response form to Medtronic. This is a safety alert notification and does not require return of devices.
We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this action, please contact Medtronic Technical Services at 1-800-595-9709.
Root Cause
Labeling design
Distribution Pattern
Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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