Boston Scientific recalls single-use polypectomy snare devices that may fail to cut polyps, risking tissue damage or bleeding during procedures. 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 single-use polypectomy snare devices that may not properly cut or remove polyps, potentially causing prolonged procedures, tissue damage, or bleeding. This could lead to serious complications like bleeding or perforation requiring surgery, though such injuries are rare.
The snare may fail to cut polyps properly, leading to incomplete removal of tissue. This could cause prolonged procedures, tissue damage, bleeding, or even perforation requiring surgery. However, severe injuries are rare and have not been reported.
Patients undergoing endoscopic procedures who use the recalled Captivator Polypectomy Snare devices are at risk. Medical professionals using these devices for polyp removal should be cautious as the snare may not function as intended.
Check for lot numbers 25143083 or 25508441 on the inner package, with expiration dates between February 2, 2023 and May 14, 2023. The product comes in a package with UPN numbers M00562371 (outer) and M00562370 (inner).
Verify the lot numbers (25143083 or 25508441) and expiration dates (February 2, 2023 to May 14, 2023) on the inner and outer packaging.
The device may not cut polyps properly, leading to tissue damage, bleeding, or perforation requiring surgery. However, severe injuries are rare and have not been reported.
Check for lot numbers 25143083 or 25508441 with expiration dates between February 2, 2023 and May 14, 2023 on the inner and outer packaging.
The recall record does not specify a remedy, so no action is required beyond checking if the product is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2763-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2763-2020 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.