Boston Scientific recalls Uphold LITE w/ Capio SLIM model M0068318170 for potential sutures breaking, which could cause pelvic organ prolapse repair failure.
Potential for Capio sutures to break and /or detach.
Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices (model M0068318170) that may have sutures breaking or detaching. This could lead to the device failing to properly reinforce pelvic tissue in women with pelvic organ prolapse.
The sutures in the device may break or detach during use, which could cause the device to fail in its intended purpose of reinforcing pelvic tissue. This might lead to the pelvic organ prolapse condition worsening or requiring additional surgery.
Women who have received the Uphold LITE w/ Capio SLIM device (model M0068318170) for pelvic organ prolapse repair are most at risk. This product is intended for use in women with this condition.
Check for the model number M0068318170 on the device. The product was sold with specific batch numbers listed in the recall notice.
Look for the model number M0068318170 on the device to confirm if it is recalled.
Reach out to Boston Scientific directly for guidance on next steps if you have the recalled device.
The recall indicates a potential risk of sutures breaking or detaching, so it is not recommended for use until the manufacturer provides further instructions.
Check the model number and contact Boston Scientific for specific instructions on what to do next.
The recalled device has model number M0068318170 and specific batch numbers listed in the recall 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-1622-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1622-2018 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.
