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 is for specific lot numbers and expiration dates.
The devices may not cut polyps effectively, leading to incomplete removal. This could cause prolonged procedures, tissue damage, or bleeding. While severe injuries are possible, they 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 risk if they have the recalled lot numbers.
Check the outer package UPN number (M00561311) and inner package UPN number (M00561310). The lot numbers 25199777, 25330546, 25374640, and 25424470 with expiration dates from February 11 to March 31, 2023 are affected.
Look for lot numbers 25199777, 25330546, 25374640, or 25424470 on the device packaging.
Boston Scientific has noted a potential inability to cut and remove polyps for these specific lot numbers, which could lead to prolonged procedures, tissue damage, or bleeding.
The device may not cut polyps effectively, causing incomplete removal. This could result in longer procedures, tissue damage, or bleeding. Severe injuries are rare and have not been reported.
Check the outer package UPN number (M00561311) and inner package UPN number (M00561310). Affected devices have lot numbers 25199777, 25330546, 25374640, or 25424470 with expiration dates from February 11 to March 31, 2023.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2760-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2760-2020 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.
