Hurricane™ RX M00545960Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08714729283874), received between Jul 25, 2017 and Dec 29, 2025 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (29 reports).

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 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-0327-2022 · 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907830 ↗
• MalfunctionDec 26, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898115 ↗
• MalfunctionOct 21, 2025Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS DILATED AND BURST BEFORE 3 ATMS WERE REACHED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON OCTOBER 26, 2025*** IT WAS REPORTED THAT THE BALLOON WAS TESTED BEFORE THE INCIDENT. HOWEVER, THE INSTRUCTIONS FOR USE (IFU), STATES THAT PRECAUTION: DO NOT PREINFLATE, PRETEST BALLOON, OR ATTEMPT TO REFOLD BALLOON INTO PROTECTIVE SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347884 ↗
• MalfunctionSep 3, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 22953946 ↗
• MalfunctionMay 6, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON FAILED TO DILATE DUE TO A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971945 ↗
• MalfunctionOct 30, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING A PAPILLARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS USED TO DILATE; BUT THE BALLOON WAS NOT INFLATED. IT WAS REPORTED THAT THE PLAN WAS TO PRESSURIZE THE BALLOON TO 8 ATM/10 MM, BUT IT WAS DAMAGED IN THE MIDDLE OF THE PROCEDURE, SO THE PRESSURE OR DIAMETER WHEN THE BALLOON RUPTURED IS UNKNOWN. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 20570565 ↗
• InjuryOct 18, 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 USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING RETRACTION OF THE BALLOON FROM THE BILE DUCT, THE TIP WAS BROKEN UPON ENDOSCOPIC VISUALIZATION. THE TIP WAS THEN RETRIEVED ENDOSCOPICALLY WITH A RETRIEVAL DEVICE. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20485529 ↗
• MalfunctionAug 22, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY/(ERCP) PROCEDURE PERFORMED. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE BALLOON POPPED ON FIRST INFLATION. THE CUSTOMER REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041298 ↗
• MalfunctionAug 22, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024724 ↗
• MalfunctionAug 7, 2024Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC BILIARY DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST AT 3 ATM. THE CUSTOMER REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 19935143 ↗
• InjuryApr 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 COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BROKE INSIDE THE COMMON BILE DUCT AND WAS DETACHED. THE DETACHED BALLOON WAS RETRIEVED. NO FURTHER EVENT INFORMATION WAS PROVIDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102184 ↗
• InjuryMar 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE ATTEMPTING TO INFLATE THE BALLOON, THE CATHETER BROKE OFF, CAUSING THE BALLOON TO DETACH INSIDE THE DUCT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BALLOON BY USING RADIAL JAW FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899563 ↗
• MalfunctionSep 19, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE PAPILLA DURING A PAPILLARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774771 ↗
• MalfunctionMay 16, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE BALLOON WAS NOTED TO BE DAMAGED AND COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION 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. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, THE CUSTOMER REPORTED THAT THE EVENT OCCURRED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942921 ↗
• MalfunctionMay 12, 2023Detachment 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 USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON DETACHED FROM THE CATHETER. 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 16921585 ↗
• MalfunctionApr 17, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE HILAR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752545 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CATHETER TORE FROM THE BALLOON WHILE PULLING OUT THE DEVICE. 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 16464505 ↗
• InjuryNov 16, 2022Detachment 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 USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING WITHDRAWAL, AFTER THE BALLOON WAS DEFLATED, THE TIP OF THE CATHETER TORE BEHIND THE DISTAL BALLOON END AND DETACHED INSIDE THE PATIENT. THE DETACHED PIECE WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS ALREADY COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807134 ↗
• MalfunctionAug 17, 2022Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF FIVE HURRICANE RX DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FIVE HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ALL FIVE BALLOONS BURST. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245797 ↗
• MalfunctionAug 17, 2022Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF FIVE HURRICANE RX DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FIVE HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ALL FIVE BALLOONS BURST. 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245659 ↗
• MalfunctionAug 17, 2022Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE HURRICANE RX DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE HURRICANE RX DILATATION BALLOONS WERE USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, ALL THREE BALLOONS BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CURRENT CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240660 ↗
• MalfunctionApr 21, 2022Burst Container or Vessel; Defective Device; Burst Container or Vessel; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON EXPLODED. THE DEVICE WAS REMOVED, AND IT WAS OBSERVED THAT A RESIDUE WOULD HAVE POTENTIALLY REMAINED IN THE PATIENT'S BODY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN CLARIFYING INFORMATION REGARDING THE ALLEGED RESIDUE TO DATE, DESPITE GOOD FAITH EFFORTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14175020 ↗
• MalfunctionSep 17, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE RX DILATATION BALLOON WERE USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH BALLOONS POPPED. THE PROCEDURE WAS COMPLETED WITH A HURRICANE RX BALLOON OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488562 ↗
• MalfunctionAug 26, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A HOLE AT THE PROXIMAL SHOULDER, THEREFORE, IT COULD NOT INFLATE PROPERLY. ADDITIONAL CLARIFICATION TO DETERMINE THE SIZE/NATURE OF THE HOLE HAS NOT BEEN PROVIDED, SO THE REPORTED EVENT WILL BE CONSIDERED A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372072 ↗
• MalfunctionJul 16, 2021Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING A PAPILLA DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12183254 ↗