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U.S. Department of Health and Human Services

Class 2 Device Recall Visualase(TM) Cooled Laser Applicator System (VCLAS) 15MM TIP

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  Class 2 Device Recall Visualase(TM) Cooled Laser Applicator System (VCLAS) 15MM TIP see related information
Date Initiated by Firm June 07, 2017
Date Posted July 03, 2017
Recall Status1 Terminated 3 on June 29, 2018
Recall Number Z-2755-2017
Recall Event ID 77623
510(K)Number K053087  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
Code Information Lot Numbers: 211158059, 211560973, 211959879, 12473141, 212707035, 211158151, 211594328, 211977586, 212503634, 212745660, 211158152, 211599898, 211987873, 212504463, 212796559, 211181212, 211628257, 212127654, 212549456, 212912501, 211181547,211908695, 212141557, 212553428, 211184941, 211916062, 212148368, 212632884,211555011, 211926889, 212434500, 212647830, 211555017, 211950736, 212438405, 212701679 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Thomas Reimann
720-890-3241
Manufacturer Reason
for Recall		 Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
FDA Determined
Cause 2		 Component design/selection
Action Medtronic sent an Urgent Medical Device Safety Alert dated June 1, 2017, to all affected customers. Actions to be taken: 1. Please examine your inventory and if any of the affected products listed above are found, immediately quarantine them for return to Medtronic. 2. Complete and follow instruction on the attached consignee response form. Sign and date the bottom of the form and then return the form to Medtronic at RS.NavFCA¿medtronic.com or fax to Medtronic Technical Services at 651-367-7075. If you have affected products, contact Medtronic Technical Services at 1-800 595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Once an RMA number is obtained, ship the affected product to Medtronic. For further questions please call (720) 890-3241.
Quantity in Commerce 214 units
Distribution US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = BIOTEX, INC.
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