Boston Scientific recalls HURRICANE RX Dilation Balloons (10mm 4cm) due to pressure loss during biliary procedures. Affected units have specific batch numbers and expiration dates. Contact for replacement.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling HURRICANE RX Dilation Balloons (10mm 4cm) used in biliary procedures because a pinhole can cause pressure loss, leading to longer surgeries. This risk affects medical devices sold between May 2022 and June 2023.
The balloon has a pinhole that can cause pressure loss or failure to maintain pressure during dilation procedures. This may lead to longer surgeries and increased risk of complications.
Healthcare professionals using these balloons for endoscopic procedures are affected. Patients undergoing biliary treatments with the recalled balloons are at risk of prolonged procedures.
Check for batch numbers listed in the recall: 25608761, 25640116, 25640117, 25644834, and other specific batches. The balloons expire between May 2022 and June 2023.
Look for batch numbers on the balloon packaging or label, such as 25608761 or 25640116.
Reach out to Boston Scientific directly for replacement or further instructions.
The balloon has a pinhole that can cause pressure loss or failure to maintain pressure during dilation procedures, leading to prolonged surgeries.
Check the batch number and contact Boston Scientific for replacement or further instructions.
Yes, patients undergoing biliary procedures with the recalled balloons may face longer surgeries due to pressure issues.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0327-2022 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.
