Boston Scientific recalls Posterior LITE w/ Capio SLIM model M0068318150 for potential sutures breaking or detaching, which could cause injury in women with pelvic organ prolapse.
Potential for Capio sutures to break and /or detach.
Boston Scientific is recalling a specific model of Posterior LITE w/ Capio SLIM surgical device for women with pelvic organ prolapse. The recall is due to a risk that the sutures might break or detach during use, which could lead to complications.
The sutures in this device could break or detach during use, potentially causing injury or complications for women who have pelvic organ prolapse. This risk occurs because the device is designed to reinforce pelvic tissue, but the sutures may fail under normal use conditions.
Women who have pelvic organ prolapse and received this specific model of Posterior LITE w/ Capio SLIM device. Those with the model number M0068318150 are most at risk.
Check for the model number M0068318150 on the device. This product was sold with specific batch numbers listed in the recall notice, including 36893, 20721161, and others.
Look for the model number M0068318150 on the device label.
Reach out to Boston Scientific directly for further instructions on the recall.
The recall indicates a potential risk that the sutures may break or detach, so it is recommended to stop using the device until further instructions are received.
Check the model number on the device. If it matches M0068318150, contact Boston Scientific for guidance on the next steps.
Yes, the recall includes specific batch numbers such as 36893, 20721161, 20867461, and others listed in the notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1623-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1623-2018 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.