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U.S. Department of Health and Human Services

Class 2 Device Recall Laser fibers

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  Class 2 Device Recall Laser fibers see related information
Date Initiated by Firm May 28, 2015
Date Posted July 21, 2015
Recall Status1 Terminated 3 on January 19, 2016
Recall Number Z-2156-2015
Recall Event ID 71534
510(K)Number K050108  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Sureflex 150 Lithotripsy Fiber, 5x, Blue;

Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
Code Information Model R-LLF150TG: All product manufactured from April 8, 2012 to April 8, 2015
Recalling Firm/
American Medical Systems Innovation Center - Silicon Valley
3070 Orchard Dr
San Jose CA 95134-2011
For Additional Information Contact Jennifer Mascioli-Tudor
408-456-3320 Ext. 6703
Manufacturer Reason
for Recall
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
FDA Determined
Cause 2
Reprocessing Controls
Action Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
Quantity in Commerce ~13,710 units - total all affected devices
Distribution Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
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 = INNOVAQUARTZ