Boston Scientific recalls SpyScope DS Access and Delivery diagnostic biliary catheters with a potential risk of bleeding due to a protruding sleeve. Affected units include specific serial numbers.
Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.
Boston Scientific is recalling certain SpyScope DS Access and Delivery diagnostic biliary catheters that may have a working channel sleeve protruding from the camera cap. This could cause minor tissue damage or significant bleeding if the catheter is used.
The working channel sleeve may protrude from the camera cap, leading to tissue damage or bleeding during medical procedures. This risk is particularly concerning in biliary procedures where precise placement is critical.
Patients who have received the SpyScope DS Access and Delivery catheter with specific serial numbers listed in the recall are affected. Medical professionals using these devices for biliary procedures are at the highest risk.
Check the serial numbers on the device: 21071349, 21186199, 21264281, 21338493, and other specific numbers listed in the recall notice. The SpyScope DS Access and Delivery diagnostic biliary catheter is used for medical procedures.
Verify if your device has one of the specific serial numbers listed in the recall notice.
The risk is minor tissue damage or significant bleeding due to a protruding sleeve from the camera cap.
Check the serial numbers on your device against the list provided in the recall notice.
The recall does not specify a remedy, so contact Boston Scientific directly for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1133-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1133-2018 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.
