Boston Scientific recalls Capio SLIM Suture Capturing Device model M0068318250 due to potential suture breakage during surgery. Affected units include specific batch numbers sold in the U.S. from 2017-2023.
Potential for Capio sutures to break and /or detach.
Boston Scientific is recalling a specific model of suture capturing device used in open surgery because it may cause sutures to break or detach. This could lead to complications during surgical procedures if the device fails.
The device may cause sutures to break or detach during surgery due to a design flaw that affects how it holds suture material. This could lead to complications if the suture material becomes loose or separates from the tissue during the procedure.
Surgical teams and hospitals that use the Capio SLIM Suture Capturing Device model M0068318250 for open surgery are most at risk. Patients undergoing procedures with this device could face complications if sutures break during surgery.
Check for the model number M0068318250 on the device. Affected units have specific batch numbers listed in the recall notice, including those from 2017 to 2023.
Look for the model number M0068318250 on the device to confirm if it is affected.
Reach out to Boston Scientific directly for assistance with the recall process.
The device may cause sutures to break or detach during surgery, which could lead to complications for patients.
Affected batch numbers include 17781206, 19335463, 20312941, and other specific numbers listed in the recall notice.
No, but surgical teams should check if they have the affected model and contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1616-2018 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.
