Class 2 Device Recall Upsylon YMesh Kit with Colpassist Vaginal Positioning Device

• Date Initiated by Firm: April 15, 2021
• Create Date: April 23, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1491-2021
• Recall Event ID: 87709
• Product Classification: Gynecological laparoscopic kit - Product Code OHD
• Product: UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach; Material No.M0068318220; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal.; ; Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. ; This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.
• Code Information: All unexpired lots: C003726 C003737 C003739 C003752 C003767 C003778 C003782 C003791 C003814 C003818 C003831 C003845 C003846 C003874 C003875 C003898 C003899 C003921 C003942 C003954 C003970 C003988 C003989 C003999 C004000 C004011 C004012 C004031 C004032 C004033 C004048 C004049 C004084 C004085 C004086 C004097 C004098 C004099 C004120 C004132 C004143 C004150 C004159 C004175 C004176 C004196 C004205 C004213 C004218 C004223 GTIN: 08714729848103
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Rebecca Kinkead Rubio; 508-683-4000
• Manufacturer Reason for Recall: Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
• FDA Determined Cause: Packaging process control
• Action: Boston Scientific issued Urgent Medical Device Product Removal on 4/15/21 via FedX. Letter states reason for recall, health risk and action to take; Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. This removal affects only the UPNs and batches listed below and in Attachment 1. No other UPNs or batches are impacted by this removal. Please cease further distribution or use of any remaining product affected by this removal immediately. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions and indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. BSC is notifying regulatory authorities of this removal as required. Please read carefully through the removal instructions included with this notification. Your local Sales Representative can answer any questions that you may have regarding this notification.
• Quantity in Commerce: 8,524 WW
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Brazil, Colombia, Estonia, Germany, Hong Kong, Australia, Canada, Costa Rica, Finland, Great Britain, Italy, Austria, Chile, Czech Republic, France, Greece, Jordan, Belgium, Lebanon, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan.
• 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.