Hurricane™ RX M00545900Recalls & reported problems

Summary

The FDA's MAUDE database contains 705 adverse event reports that list this exact device (DI 08714729283812), received between Sep 10, 2018 and Sep 28, 2026 — classified as 1 death, 29 injuries, 675 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (373 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. 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-0321-2022 · 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 705 reports, in the reporter's own words as published by the FDA.

• DeathSep 28, 2026Leak/Splash; Use of Device Problem; Material Integrity Problem

  It was reported to Boston Scientific Corporation that imaging revealed a shadow in the pancreatic duct; therefore, a SpyScope DS II, Tandem XL, Hurricane RX, SpyBite Max, Extractor RX Retrieval Balloon, and Trapezoid RX were used for examination during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026. Upon examination, intraductal papillary mucinous neoplasm lesions (IPNM) were observed in the pancreatic neck and tail, along with a pancreatic duct stone. A Hurricane 4 mm, 4 cm balloon was used to dilate the pancreatic duct. After using the SpyBite Max for biopsy, the physician attempted stone extraction using an Extractor balloon and a Trapezoid basket, but these attempts were unsuccessful. The physician then attempted to use a Hurricane 4 mm, 4 cm balloon to drag the stone out. At the moment traction was applied, the Hurricane balloon may have been damaged, and contrast medium was observed flowing into the pancreatic duct. It was uncertain at that time whether any injury to the pancreatic duct had occurred.On (b)(6) the patient developed pancreatitis. On (b)(6) the patient underwent partial pancreatectomy, with resection of the pancreatic

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 50926355 ↗
• MalfunctionSep 18, 2026Inflation Problem; Use of Device Problem; Material Integrity Problem

  It was reported to Boston Scientific Corporation that a Hurricane RX Dilatation Balloons Dilatation Balloon was being prepared to be used in the common bile duct during an Endoscopic retrograde cholangiopancreatography (ERCP) Management procedure for stenosis and pain in lower abdomen performed on (b)(6) 2026.During unpacking, it was noticed that the balloon was damaged and could not be inflated outside the patient. The procedure was completed with another Hurricane RX Dilatation Balloons Dilatation Balloon.There were no patient complications reported as a result of this event. The patients 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 balloon was pre-inflated outside of the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813127 ↗
• MalfunctionAug 13, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230537 ↗
• MalfunctionJul 29, 2026Leak/Splash; Use of Device Problem; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073592 ↗
• MalfunctionMay 25, 2026Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY TRACT DURING A DILATATION PROCEDURE PERFORMED FOR THE TREATMENT OF STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS USED BUT SUBSEQUENTLY RUPTURED AT 4 ATM AND LEAKAGE OBSERVED FROM THE SIDE OF THE BALLOON. A VIDEO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE BALLOON WAS LEAKING. 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 25272446 ↗
• MalfunctionMay 7, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON WAS DETACHED INTO THE PATIENT. 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 25119320 ↗
• MalfunctionMar 25, 2026Leak/Splash; Material Split, Cut or Torn

  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) AND METAL STENT IMPLANTATION PROCEDURE FOR STENOSIS OF THE UPPER AND MIDDLE SEGMENT PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME MODEL. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689564 ↗
• MalfunctionOct 15, 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON (B)(6) 2025. DURING THE PROCEDURE, THE HURRICANE BALLOON BURST AT 11 ATM. 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 23279639 ↗
• MalfunctionOct 3, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE HURRICANE RX DILATATION BALLOON BURST BEFORE EVEN 3 ATMS WERE REACHED. IT WAS REPORTED THAT NO PART OF THE BALLOON DETACHED AND FELL INTO THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND HURRICANE RX DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 23215973 ↗
• MalfunctionOct 3, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE HURRICANE RX DILATATION BALLOON BURST BEFORE EVEN 3 ATMS WERE REACHED. IT WAS REPORTED THAT NO PART OF THE BALLOON DETACHED AND FELL INTO THE PATIENT. THE SAME PROBLEM OCCURRED WITH THE SECOND HURRICANE RX DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD 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 23215964 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA AND BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGIOCARCINOMA ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN USED A BALLOON TO DILATE THE LEFT HEPATIC DUCT. THE WIRE WAS LEFT IN PLACE FOR STENT PLACEMENT LATER. AFTER DILATION, THE PHYSICIAN PULLED THE CATHETER OUT SO HE COULD SEND ANOTHER WIRE AND DILATING BALLOON INTO THE RIGHT HEPATIC. ONCE THE CATHETER PASSED THROUGH THE SCOPE AND OUT THE TIP TO RE CANNULATE THE DUCT, IT WAS NOTICED THAT A BLACK PORTION OF THE PREVIOUS CATHETER IN THE DUCT OVER THE FIRST WIRE. IT WAS REPORTED THAT THE DETACHED PIECE WAS COMPLETELY RETRIEVED UPON PULLING OUT THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTO OF THE DEVICE OUTSIDE THE PATIENT PROVIDED BY THE CUSTOMER SHOWS THE RX TUNNEL OF THE DEVICE AND CATHETER KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000766 ↗
• MalfunctionJul 16, 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 RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525355 ↗
• MalfunctionJul 4, 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON POPPED. NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. 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 22403778 ↗
• MalfunctionJul 4, 2025Burst 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 BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON POPPED. 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 22403717 ↗
• MalfunctionMay 30, 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 AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PRODUCT WAS PREPARED AND BACKLOADED OVER A WIRE, THEN ADVANCED THROUGH THE DUODENOSCOPE INTO THE COMMON BILE DUCT, WITH A PORTION OF THE BALLOON STICKING OUT OF THE AMPULLA. USING THE ENCORE INFLATION DEVICE, THE BALLOON WAS INFLATED UNTIL IT REACHED THE DESIGNATED ATM PRESSURE, AT WHICH POINT IT BURST AT 8 ATM. 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. 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 BALLOON WAS INFLATED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117829 ↗
• MalfunctionMay 23, 2025Burst 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 BILE DUCT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE INFLATED IN THE PATIENT'S COMMON BILE DUCT (CBD) THE BALLOON POPPED. 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 22080872 ↗
• MalfunctionMay 19, 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 BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PRODUCT WAS OPENED FOR USE, IT WAS OBSERVED TO HAVE 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 22044590 ↗
• MalfunctionMay 16, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON HAD A PINHOLE UPON INFLATION AT THE DILATION SITE CONTRAST SOLUTION SHOT OUT OF THE BALLOON. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 6MM 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 A BALLOON LONGITUDINAL TEAR. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036140 ↗
• MalfunctionMay 12, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE HILUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE DILATING, THE BALLOON RUPTURED AND LEAKED. A SECOND AND THIRD BALLOON DEVICE WERE ATTEMPTED TO BE USED BUT BOTH BALLOONS ALSO RUPTURED AND LEAKED. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOONS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A STEP DILATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003492 ↗
• MalfunctionMay 12, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE HILUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, WHILE DILATING, THE BALLOON RUPTURED AND LEAKED. A SECOND AND THIRD BALLOON DEVICE WERE ATTEMPTED TO BE USED BUT BOTH BALLOONS ALSO RUPTURED AND LEAKED. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOONS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A STEP DILATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003488 ↗
• MalfunctionMay 12, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE HURRICANE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE HILUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE DILATING, THE BALLOON RUPTURED AND LEAKED. A SECOND AND THIRD BALLOON DEVICE WERE ATTEMPTED TO BE USED BUT BOTH BALLOONS ALSO RUPTURED AND LEAKED. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOONS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A STEP DILATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003325 ↗
• MalfunctionMay 7, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) 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 THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976847 ↗
• MalfunctionMay 1, 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 A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, 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 21943590 ↗
• MalfunctionMay 1, 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 A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, 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 21943576 ↗
• MalfunctionMay 1, 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 A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, 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 21943407 ↗