Boston Scientific recalls Captivator/Captiflex/Sensation Short Throw Polypectomy Snares with incomplete pouch seals that may lead to device failure during use. Affected units include specific box and pouch model numbers.
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
Boston Scientific is recalling certain polypectomy snare devices due to incomplete pouch seals that could cause the device to fail during medical procedures. This hazard poses a risk of device malfunction if used on patients.
The packaging has an incomplete seal on the inner pouch, which could lead to the device failing during medical procedures. Users have reported this issue before the device is used on patients.
Medical professionals using the Captivator, Captiflex, or Sensation Short Throw Polypectomy Snares devices are most at risk. Patients receiving these procedures may be affected if the device fails.
Check for specific model numbers: Outer box UPN M00560311 (Box 5), M00560321 (Box 5), M00562651 (Box 5), M00562652 (Box 20), M00562671 (Box 5), M00562672 (Box 20), M00562673 (Box 40), M00562691 (Box 5), and other listed combinations. The outer box GTIN codes are also listed in the recall notice.
Inspect the inner pouch seal for completeness before use. If the seal appears incomplete, do not use the device.
The recalled devices include specific model numbers: Outer box UPN M00560311 (Box 5), M00560321 (Box 5), M00562651 (Box 5), M00562652 (Box 20), M00562671 (Box 5), M00562672 (Box 20), M00562673 (Box 40), M00562691 (Box 5), and other combinations listed in the recall notice.
Check the outer box GTIN and inner pouch GTIN codes listed in the recall notice. Affected units have specific model numbers and lot/batch numbers as detailed in the recall.
Inspect the inner pouch seal for completeness before use. If the seal appears incomplete, do not use the device. Boston Scientific does not provide a replacement or refund for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1170-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1170-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
