Hurricane™ RX M00545910Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729283829), received between Sep 6, 2018 and Dec 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Oct 21, 2021Open, Classified

   Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

   Z-0322-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Sep 16, 2020Open, Classified

   RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

   Z-0286-2021 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST BEFORE REACHING 11 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9409363 ↗
• MalfunctionSep 6, 2018Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO HURRICANE RX DILATION BALLOONS WERE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS LEAKING AND HAD A BLATANT HOLE. THE SAME ISSUE OCCURRED WITH THE SECOND HURRICANE RX DILATION BALLOON. A PHOTO SENT BY THE CUSTOMER SHOWED THAT THE BALLOON LEAKED DUE TO A PINHOLE AT THE PROXIMAL END. REPORTEDLY, THE PHYSICIAN PULLED OUT THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH A CRE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853595 ↗