Boston Scientific recalls HURRICANE RX 10mm 2cm dilation balloons for endoscopic use due to pressure failure risk during biliary procedures. Affected batches sold through 2023.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling certain HURRICANE RX dilation balloons for endoscopic procedures because a pinhole can cause pressure loss, leading to longer surgeries. This risk affects medical professionals using the balloons in biliary treatments.
The balloon's pinhole can cause pressure loss during dilation procedures, making it difficult to maintain proper pressure. This may lead to longer surgeries and increased risk for patients.
Medical professionals who use the recalled balloons for endoscopic procedures in biliary tree treatments. Patients undergoing these procedures with the affected balloons are at risk of prolonged surgery.
Check for the batch numbers listed: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787. The balloons were sold with expiration dates from May 2022 to May 2023.
Look for batch numbers on the balloon packaging: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787
The balloons have a pinhole that can cause pressure loss during dilation procedures, leading to longer surgeries.
Check the batch numbers listed: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787. The balloons were sold with expiration dates from May 2022 to May 2023.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0326-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0326-2022 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.
