Device 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.
Z-1672-2016
Product summary
- Event
- Event 74096
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120
- Official record key
device-enforcement:Z-1672-2016
Official wording
Reason: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Code information: All lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP
Distribution pattern: Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Derived failure modes
-
Unknown
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.