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U.S. Department of Health and Human Services

Class 2 Device Recall Visualase Cooled Laser Applicator System (VCLAS)

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 Class 2 Device Recall Visualase Cooled Laser Applicator System (VCLAS)see related information
Date Initiated by FirmMay 09, 2016
Date PostedMay 16, 2016
Recall Status1 Terminated 3 on December 19, 2016
Recall NumberZ-1672-2016
Recall Event ID 74096
510(K)NumberK053087 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductVisualase 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.
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 
FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information ContactTom Reimann
720-890-3241
Manufacturer Reason
for Recall		Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
FDA Determined
Cause 2		Labeling design
ActionMedtronic 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.
Quantity in Commerce120
DistributionDistributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEX
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