Boston Scientific Recalls Posterior LITE Sutures Due to Breakage Risk
Boston Scientific Corporation is recalling 1,541 units of the Posterior LITE w/ Capio SLIM device because the sutures may break or detach.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with a potential for structural failure (suture breakage/detachment) which poses a significant risk of injury. While no specific injuries are reported in the text, the nature of the defect in an implantable device warrants a Severe classification due to the high risk of harm if the device fails.
Plain-English summary
Boston Scientific Corporation has initiated a voluntary recall affecting 1,541 units of the Posterior LITE w/ Capio SLIM device, model number M0068318150. This product is indicated for tissue reinforcement in women with pelvic organ prolapse.
The recall was prompted by reports or potential issues regarding the Capio sutures used in the device. Specifically, there is a risk that these sutures may break and/or detach from the implant.
The affected units are distributed worldwide, including in the United States, 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 Tobet, 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.
Consumers who possess this device should contact Boston Scientific Corporation for further instructions. The company can be reached at 1-800-BOSTON-5 (1-800-267-8665) or via their website at www.bostonscientific.com.
The recalled product
- Product
- Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,541
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 11 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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