Boston Scientific recalls certain Captivator Polypectomy Snare devices due to potential inability to cut and remove polyps, which could lead to prolonged procedures, tissue damage, or bleeding. Affected units have specific lot numbers and expiration dates.
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
Boston Scientific is recalling certain Captivator Polypectomy Snare devices because they may not cut or remove polyps properly. This could cause longer procedures, tissue damage, or bleeding. The recall affects specific lot numbers and expiration dates.
The snare may not cut or remove polyps as intended, leading to longer procedures, tissue damage, or bleeding. In severe cases, this could cause bleeding that requires surgery, though such injuries are rare and have not been reported.
Medical professionals using the Captivator Polypectomy Snare during endoscopic procedures are most at risk. Patients undergoing polyp removal with these devices could experience complications if the snare fails to function correctly.
Check the outer package UPN numbers: M00561291 or inner package UPN number: M00561290. The device has specific lot numbers (25170944, 25219286, 25368742, 25412118, 25508371) and expiration dates from February 5, 2023 through May 13, 2023.
Look for lot numbers 25170944, 25219286, 25368742, 25412118, or 25508371 on the device packaging.
Reach out to Boston Scientific for guidance on next steps if you have the affected device.
The device may not cut or remove polyps properly, which could lead to longer procedures, tissue damage, or bleeding. Severe injuries like bleeding requiring surgery are rare and have not been reported.
Check the outer package UPN number M00561291 or inner package UPN number M00561290. Affected devices have specific lot numbers (25170944, 25219286, 25368742, 25412118, 25508371) and expiration dates from February 5, 2023 through May 13, 2023.
No, but if you have the affected device, contact Boston Scientific for guidance. The risk is low and severe injuries have not been reported.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2759-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2759-2020 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.
