Boston Scientific recalls HURRICANE RX 8mm 2cm dilation balloons for endoscopic procedures due to risk of pressure loss during biliary tree dilation. Affected units have specific batch numbers and expiration dates.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling certain HURRICANE RX 8mm 2cm dilation balloons used in endoscopic procedures. The balloons may develop a pinhole, causing pressure loss during use and prolonging the procedure. This could lead to complications if the procedure is not completed safely.
The balloons can develop a pinhole, which causes pressure to drop or fail to maintain pressure during dilation. This may prolong the procedure, increasing the risk of complications such as tissue damage or infection.
Healthcare professionals who use these balloons for endoscopic procedures on the biliary tree and Sphincter of Oddi are most at risk. Patients undergoing these procedures with the recalled balloons may face extended treatment times.
Check the batch numbers listed: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. The balloons expire between May 2022 and May 2023.
Review the batch numbers listed in the recall notice to determine if your balloon is affected.
Reach out to Boston Scientific for guidance on next steps if you have the recalled balloons.
The balloons may develop a pinhole, causing pressure loss or failure to maintain pressure during use, which can prolong the procedure.
Check the batch numbers: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. The balloons expire between May 2022 and May 2023.
Contact Boston Scientific for guidance on next steps if you have the recalled balloons.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0324-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0324-2022 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.
