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U.S. Department of Health and Human Services

Class 2 Device Recall Visualase Cooled Laser Applicator System

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  Class 2 Device Recall Visualase Cooled Laser Applicator System see related information
Date Initiated by Firm July 08, 2019
Create Date May 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-1905-2020
Recall Event ID 85354
510(K)Number K071328  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Visualase Cooled Laser Applicator System Tubing Set kits

Product numbers:
VCLAS 9735559, 3mm tip/1.65mm catheter
VCLAS 9735560, 10mm tip/1.65mm catheter
VCLAS 9735561, 15mm tip/1.85mm catheter
Code Information All kits with lot numbers from 0211041602 through 0217695790  
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200
Manufacturer Reason
for Recall		 The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm issued its first customer notification and customer response form on 7/8/2019. On 7/16/2019, a second notification was issued to allow customers to identify recalled product by lot number. On 10/3/2019, the firm issued a third customer notification to include three additional affected lots. The firm requested customers examine inventory for affected lot numbers and quarantine for return to the firm and to complete the attached customer response form.
Quantity in Commerce 4654 units
Distribution US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = BIOTEX, INC.
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