Hurricane™ RX M00545950Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729283867), received between Nov 12, 2024 and Nov 12, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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-0326-2022 · Root cause: Device Design · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BROKE OFF FROM THE CATHETER UPON INFLATION IN THE BILE DUCT. THE PHYSICIAN RETRIEVED THE DETACHED BALLOON FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20669635 ↗