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.
This recall has been terminated (originally issued May 16, 2016).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- May 9, 2016
- Posted
- May 16, 2016
- Terminated
- December 19, 2016
- Recall Number
- Z-1672-2016
- Quantity
- 120
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Distribution
Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Lot / Code Info
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
Root Cause
Labeling design
Action Taken
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.