FDA-Device2018-05-16Class II
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Hazard
Potential for Capio sutures to break and /or detach.
Sold states
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.
Affected count
1,541
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2018More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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