Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1618-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 12, 2018

Date Posted: May 16, 2018

Recall Number: Z-1618-2018

Event ID: 79608

Reason for Recall:

Potential for Capio sutures to break and /or detach.

Status: Terminated

Product Quantity: 1,258

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated