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U.S. Department of Health and Human Services

Class 2 Device Recall Capio Open Access

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  Class 2 Device Recall Capio Open Access see related information
Date Initiated by Firm February 12, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-1619-2018
Recall Event ID 79608
Product Classification Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Product Capio Open Access Box 4 (Capio OPC); Model #M0068311251.

Intended for use in general suturing applications during open or endoscopic
surgery to assist in the placement of suture material in tissues at the operative site.
Code Information UDI:08714729257615. Batch numbers:  17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 20146415 17748695 18952185 20151917 17758603 18956329 20225741 17763024 18960345 20225743 17791930 19046994 20341445 17970678 19046996 20341447 18129693 19046998 20560166 18134147 19173285 20639024 18135271 19225756 20706637 18229178 19329479 20711254 18281817 19437996 20713128 18286295 19442739 20822293 18357019 19560316 20833214 18362244 19646043 20834317 18430411 19646222 20838382 18488288 19659042 21069563 18605754 19824767 21081751 18606004 19835267 21258659 18611631 19856248 21362105 19975069 21362107  
Recalling Firm/
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Nicole Pshon
Manufacturer Reason
for Recall
Potential for Capio sutures to break and /or detach.
FDA Determined
Cause 2
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 21,051
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.