Recalls / —

—#162761

Product

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

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

K932553

Affected lot / code info

UDI:08714729516545. Batch numbers:  18011270 18245411 19491588 18011271 18654941 19668541 18229999 18881759 19987267 20602764 19173286 20382965 20602764 20850569 21234964

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 #162761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.