Boston Scientific recalls HURRICANE RX 6mm 2cm dilation balloons for endoscopic procedures due to pinhole leaks causing pressure loss during biliary tree dilation. Affected batches expire May 2023.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Boston Scientific is recalling HURRICANE RX 6mm 2cm dilation balloons used for biliary tree procedures because pinholes can cause pressure loss, leading to longer procedures. This is a safety issue for patients undergoing endoscopic dilation.
The balloons have pinholes that cause pressure loss during procedures. This can lead to prolonged dilation time, increasing the risk of complications like tissue damage or infection. The issue occurs in normal use during endoscopic procedures.
Patients undergoing endoscopic dilation procedures for biliary tree strictures or Sphincter of Oddi issues who use the recalled balloons. Medical professionals using these balloons for procedures are most at risk.
Check for the HURRICANE RX 6mm 2cm dilation balloon model. Affected batches include numbers from 25623385 to 27400203, with expiration dates between May 2022 and May 2023.
Identify the batch number on the balloon packaging, which should be between 25623385 and 27400203.
Boston Scientific will provide instructions for replacement or repair if you have the recalled batch.
The balloons have pinholes that cause pressure loss during procedures, leading to prolonged dilation time and potential complications.
Contact Boston Scientific directly for instructions on replacement or repair based on your batch number.
Yes, prolonged procedures due to pressure loss could increase risks of tissue damage or infection.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0322-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0322-2022 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.
