Boston Scientific recalls Captivator and Captiflex single-use polypectomy snare devices with incomplete pouch seals that could lead to device failure during use. Affected units include specific model numbers and batch dates.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Boston Scientific is recalling Captivator and Captiflex single-use polypectomy snare devices because the packaging seal may be incomplete. This could cause the device to fail during medical procedures, potentially leading to patient injury.
The packaging seal on the inner pouch may not close properly, which could allow the device to become contaminated or malfunction during use. This might cause the device to fail while removing polyps, potentially leading to injury.
Medical professionals using these devices for polyp removal are most at risk. Patients undergoing procedures with these devices may be affected if the seal fails.
Check for the outer box GTIN: 08714729019251, 08714729019312, 08714729019336, 08714729019350, 08714729019411, or 08714729501640. The inner pouch GTIN is 08714729747680, 08714729747833, 08714729747857, 08714729747871, 08714729747932, 08714729747956, or 08714729747994. Affected units have specific batch numbers listed in the recall.
Verify the outer box GTIN and inner pouch GTIN numbers to confirm if your device is affected by this recall.
Reach out to Boston Scientific directly for further assistance or to confirm if your device is part of the recall.
The packaging seal on the inner pouch may be incomplete, which could cause the device to fail during medical procedures.
Check the GTIN numbers on your device packaging to see if it's affected. Contact Boston Scientific for further instructions.
Yes, specific batch numbers like 24725319, 24782695, 24842597, and others are listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1168-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1168-2021 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.
