Boston Scientific recalls HURRICANE RX 4mm 2cm dilation balloons for endoscopic procedures due to risk of pressure loss during biliary tree dilation. 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 2cm dilation balloons used in endoscopic procedures because a pinhole can cause pressure loss, leading to longer procedures. This risk affects patients undergoing biliary tree dilation.
The balloon can develop a pinhole, causing it to lose pressure or fail to maintain pressure during dilation. This leads to prolonged procedures, which can increase risks for patients undergoing endoscopic treatments.
Patients undergoing endoscopic procedures for biliary tree strictures or sphincter of Oddi issues may be affected. Medical professionals using the device during procedures are at risk.
Check for lot numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. The balloons were sold with expiration dates from May 19, 2022, to May 13, 2023.
Identify the lot number on the balloon packaging to determine if it's affected.
Inform your doctor or healthcare provider about the recall if you use this device during procedures.
The balloons can develop a pinhole, causing pressure loss or failure to maintain pressure during dilation procedures.
Check the lot number against the list: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699.
No, but you should check the lot number and contact your healthcare provider if you use this device during procedures.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0320-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0320-2022 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.
