—#162768

Product

Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.

FDA product code: PWI — Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K122459
Affected lot / code info: GTIN: 08714729854548 Batch numbers: 36893 20721161 20867461 39699 20750829 20884690 47724 20750830 20884691 49915 20750831 20884692 49916 20774546 21021770 52597 20803727 21250250 56828 20803728 21320277 58771 20803729 21351865 60410 20807399 21359456 60770 20807700 ML00003061 62154 20807701 ML00003213 62509 20830041 ML00003329 20720887 20830060 ML00003360 20720888 20830202 20720889 20865779

Why it was recalled

Potential for Capio sutures to break and /or detach.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-02-12
Posted by FDA: 2018-05-04
Terminated: 2020-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162768. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.