Class 2 Device Recall Uphold LITE w/ Capio SLIM

• Date Initiated by Firm: February 12, 2018
• Date Posted: May 04, 2018
• Recall Status: Terminated on April 10, 2020
• Recall Number: Z-1622-2018
• Recall Event ID: 79608
• 510(K)Number: K122459
• Product Classification: Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
• Product: Uphold LITE w/ Capio SLIM; Model #M0068318170.; ; Indicated for tissue reinforcement in women with pelvic organ prolapse.
• Code Information: UDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Nicole Pshon ; 763-494-1133
• Manufacturer Reason for Recall: Potential for Capio sutures to break and /or detach.
• FDA Determined Cause: Device Design
• Action: Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.
• Quantity in Commerce: 24,126
• Distribution: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
• 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 = PWI and Original Applicant = Boston Scientific Corporation