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Recall Observatory FDA recall evidence

Device product

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

Z-1618-2018

February 12, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 79608
Status
Terminated
Classification
Class II
Quantity
1,258
Official record key
device-enforcement:Z-1618-2018

Official wording

Reason: Potential for Capio sutures to break and /or detach.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for Capio sutures to break and /or detach.