Boston Scientific recalls HURRICANE RX 8mm 4cm dilation balloons with pinhole defects causing prolonged procedures. Affected batches listed in recall. Stop using immediately.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling HURRICANE RX 8mm 4cm dilation balloons that may have pinholes. These defects can cause pressure loss during endoscopic procedures, leading to longer surgeries than intended. This is a serious risk for patients undergoing biliary tree treatments.
The balloons may have pinholes that cause pressure loss during dilation procedures. This can lead to prolonged surgery times, increasing the risk of complications for patients undergoing endoscopic treatments of the biliary tree.
Patients using the HURRICANE RX 8mm 4cm dilation balloons for endoscopic biliary tree procedures are affected. Medical professionals who have the specific batch numbers listed in the recall are most at risk.
Check the batch numbers listed in the recall (25608760, 25612672, and other numbers) on the balloon packaging. The balloons are used for endoscopic dilation of biliary tree strictures and the Sphincter of Oddi.
Discontinue use of the recalled HURRICANE RX 8mm 4cm dilation balloons if you have them.
HURRICANE RX 8mm 4cm dilation balloons for endoscopic dilatation of biliary tree strictures and the Sphincter of Oddi.
Batches 25608760, 25612672, 25649815, and other numbers listed in the recall record.
Pinholes in the balloons can cause pressure loss during procedures, leading to prolonged surgery times and potential complications.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0325-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0325-2022 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.
