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 and remove polyps properly. This could cause 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 to fix the issue.
Patients undergoing endoscopic procedures who use the recalled Captivator Polypectomy Snare devices are most at risk. Healthcare providers who have the affected lot numbers should check their inventory.
Check the outer package UPN numbers: M00562402 or inner package UPN: M00562400. The lot numbers include 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, 25402321. Expiration dates range from January 28, 2023 to March 24, 2023.
Look for the outer package UPN number M00562402 or inner package UPN number M00562400 on the device packaging.
The device may not cut and remove polyps properly, which could lead to longer procedures, tissue damage, or bleeding. Serious injuries are rare but possible.
Check the outer package UPN number M00562402 or inner package UPN number M00562400. The lot numbers include 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, 25402321.
The recall does not specify a remedy; the device may need to be replaced if it is part of the affected lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2765-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2765-2020 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.
