Boston Scientific recalls certain Captivator Polypectomy Snare devices due to potential inability to cut and remove polyps, which could cause 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 and remove polyps properly. This could lead to longer procedures, tissue damage, or bleeding. The risk of serious injury is rare but possible.
The snare may not cut polyps effectively, leading to incomplete removal. This could cause prolonged procedures, tissue damage, or bleeding. In severe cases, it might require surgery, but such injuries are rare and have not been reported.
Patients undergoing endoscopic procedures who use the recalled Captivator Polypectomy Snare devices are affected. Medical professionals using the devices for polyp removal are at higher risk.
Check the outer package UPN numbers: M00562341 or inner package UPN: M00562340. The lot numbers listed are 25077093, 25164173, 25185062, 25187234, 25226123, 25255681, 25336754, 25403003, 25508379, 25524901. Expiration dates range from January 20, 2023 to May 14, 2023.
Verify the outer package UPN number (M00562341) or inner package UPN number (M00562340) on the device.
The device may not cut polyps properly, leading to prolonged procedures, tissue damage, or bleeding. Serious injuries are rare and have not been reported.
Check the outer package UPN number (M00562341) or inner package UPN number (M00562340). The lot numbers listed are 25077093 through 25524901 with expiration dates from January 20, 2023 to May 14, 2023.
No, the recall does not require immediate discontinuation. The risk of serious injury is rare and has 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-2762-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2762-2020 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.
