Boston Scientific recalls HURRICANE RX 4mm 4cm dilation balloons for endoscopic procedures due to pinhole defects causing pressure loss during procedures. Affected units have specific lot numbers and expiration dates.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling HURRICANE RX 4mm 4cm dilation balloons used in endoscopic procedures because a pinhole defect can cause pressure loss, leading to prolonged procedures. This is a safety issue for patients undergoing biliary tree or sphincter of Oddi procedures.
The balloons have a pinhole defect that causes pressure loss during use. This can lead to the procedure taking longer than intended, which increases the risk of complications for patients undergoing endoscopic dilation of strictures.
Patients undergoing endoscopic procedures for biliary tree or sphincter of Oddi strictures are most at risk. Healthcare providers using these balloons in medical procedures may also be affected.
Check for the product name 'HURRICANE RX Dilation Balloon 4mm 4cm' with lot numbers listed in the recall notice (25576719 to 27408924) and expiration dates between May 10, 2022 and May 31, 2023.
Identify the lot number and expiration date on the balloon packaging to confirm if it's affected.
Reach out to Boston Scientific directly for assistance with the recall process.
The balloons have a pinhole defect that causes pressure loss during procedures, potentially leading to prolonged treatment.
Check the lot number and expiration date on the packaging. If affected, contact Boston Scientific for guidance.
The recall states that pressure loss can cause prolonged procedures, but does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0321-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0321-2022 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.
