Boston Scientific recalls Captivator II Single-Use Polypectomy Snares 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 II Single-Use Polypectomy Snares due to an incomplete pouch seal that may cause the device to fail during medical procedures. This could lead to complications for patients if the device does not function properly.
The pouch seal may not close properly, which could allow the device to malfunction during medical procedures. This might lead to the device not functioning as intended, potentially causing complications for the patient.
Healthcare professionals using the Captivator II devices for polyp removal are most at risk. Patients receiving the procedure may also be affected if the device fails during use.
Check for model numbers M00561191, M00561190, M00561221, M00561222, M00561223, or M00561233 on the outer box. The affected units were sold with specific batch dates and lot numbers listed in the recall notice.
Look for model numbers M00561191, M00561190, M00561221, M00561222, M00561223, or M00561233 on the outer box.
The recall is due to an incomplete pouch seal that could cause the device to malfunction during medical procedures.
Check the model numbers and batch dates listed in the recall notice to see if your device is affected. If it is, contact Boston Scientific for further instructions.
The recall indicates a potential for device malfunction, but the official notice does not specify a risk of serious injury.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1169-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1169-2021 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.
