Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-1622-2018)

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:

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Product Classification:

Class II

Date Initiated: February 12, 2018

Date Posted: May 16, 2018

Recall Number: Z-1622-2018

Event ID: 79608

Reason for Recall:

Potential for Capio sutures to break and /or detach.

Status: Terminated

Product Quantity: 24,126

Code Information:

UDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142

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