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U.S. Department of Health and Human Services

Class 3 Device Recall GreenLight HPSEA Laser Fibers

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  Class 3 Device Recall GreenLight HPSEA Laser Fibers see related information
Date Initiated by Firm May 31, 2022
Create Date July 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-1392-2022
Recall Event ID 90458
510(K)Number K062719  
Product Classification Powered laser surgical instrument - Product Code GEX
Product GreenLight HPSEA Laser Fibers, UPN 0010-2092
Code Information UDI-DI (GTIN): 00878953005522 Lot: 27770466
Recalling Firm/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca Kinkead Rubio
Manufacturer Reason
for Recall
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.
FDA Determined
Cause 2
Software Manufacturing/Software Deployment
Action On May 31, 2022, the firm distributed Urgent Medical Device Product Removal letters to affected customers. Customers were instructed to immediately segregate and return the product to Boston Scientific.
Quantity in Commerce 57
Distribution Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
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 = LASERSCOPE