Recalled Boston Scientific HURRICANE RX 6mm 4cm dilation balloon for endoscopic procedures due to pressure loss risk. Batches 25576770-27384715 (exp. 05/10/2022-05/26/2023) may cause prolonged procedures.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling its HURRICANE RX 6mm 4cm dilation balloon for endoscopic procedures. The balloon may develop a pinhole, causing pressure loss that could lead to prolonged procedures. This is a safety issue for medical professionals using the device.
The balloon has a pinhole that can cause pressure loss or failure to maintain pressure during endoscopic dilation. This may lead to prolonged procedures, increasing the risk of complications for patients.
Medical professionals who use this balloon during endoscopic procedures are affected. Patients undergoing biliary tree or sphincter of Oddi dilation may be at risk if the balloon fails during treatment.
Check the batch numbers listed in the recall: 25576770 through 27384715. The balloons were manufactured between May 10, 2022 and May 26, 2023.
Look for batch numbers on the balloon packaging between 25576770 and 27384715.
Contact Boston Scientific for guidance on next steps if you have the recalled batch.
The balloon has a pinhole that can cause pressure loss or failure to maintain pressure during endoscopic dilation procedures.
Check the batch numbers on the packaging: 25576770 through 27384715 (manufactured May 10, 2022 to May 26, 2023).
No, but you should check the batch number and contact Boston Scientific if you have the recalled batch.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0323-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0323-2022 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.
