Hurricane™ RX M00545920Recalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 08714729283836), received between Aug 31, 2018 and Sep 14, 2026 — classified as 15 injuries, 196 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (97 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 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-0323-2022 · 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 25 most recent of 211 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Inflation Problem; Material Integrity 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 Cholangioscopy procedure to treat strictures performed on (b)(6) 2026.During procedure, the balloon would not inflate because it appeared to have a cut. The procedure was completed with another of the same device. No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event. The patient condition following procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756655 ↗
• MalfunctionAug 14, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245645 ↗
• MalfunctionAug 13, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240138 ↗
• MalfunctionJun 19, 2026Burst 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) 2026. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 25568558 ↗
• MalfunctionMay 13, 2026Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE DILATATION BALLOON USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE DILATATION BALLOONS WERE ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE. IT WAS REPORTED THAT THE BALLOON RUPTURED. ADDITIONALLY, THE SAME PROBLEM HAPPENED ON THE OTHER HURRICANE DILATATION BALLOON DEVICE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE 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 PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166481 ↗
• MalfunctionMay 13, 2026Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE DILATATION BALLOON USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HURRICANE DILATATION BALLOONS WERE ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE. IT WAS REPORTED THAT THE BALLOON RUPTURED. ADDITIONALLY, THE SAME PROBLEM HAPPENED ON THE OTHER HURRICANE DILATATION BALLOON DEVICE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE 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 PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166480 ↗
• MalfunctionMay 8, 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 BILE DUCT PAPILLARY OPENING DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PANCREATIC DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST AT 6 ATM AND THE CONTRAST MEDIUM LEAKED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124311 ↗
• MalfunctionFeb 26, 2026Burst 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 A DILATION PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS INFLATED WITHIN THE PRESSURE LIMITS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU); HOWEVER, THE BALLOON RUPTURED DURING DILATION. 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. 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 24464751 ↗
• MalfunctionOct 21, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON WAS ALREADY BROKEN BEFORE IT ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344658 ↗
• MalfunctionOct 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, IT WAS REPORTED THAT BALLOON BREAK RIGHT AWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE BALLOON BURST. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280343 ↗
• MalfunctionOct 3, 2025Material Integrity Problem; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOON USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURES PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON BROKE/FRACTURED. A SECOND HURRICANE RX DILATATION BALLOON OF THE SAME LOT WAS USED, AND THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL METHOD/DEVICE USED. 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 23213713 ↗
• MalfunctionOct 3, 2025Material Integrity Problem; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATATION BALLOON USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STRICTURES PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BALLOON BROKE/FRACTURED. A SECOND HURRICANE RX DILATATION BALLOON OF THE SAME LOT WAS USED, AND THE SAME PROBLEM OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL METHOD/DEVICE USED. 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 23213711 ↗
• MalfunctionSep 4, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC PAPILLARY DILATATION BALLOON (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 HAD ALREADY BEEN 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 22974178 ↗
• MalfunctionAug 14, 2025Leak/Splash; Leak/Splash

  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, WHEN INFLATING THE BALLOON, IT WAS LEAKING AT THE CONNECTION BETWEEN THE CATHETER AND THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. THE ANATOMY LOCATION OF THE PROCEDURE IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 22812933 ↗
• MalfunctionJul 25, 2025Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT PANCREATIC DUCT STONES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS INFLATED TO ONE ATMOSPHERIC PRESSURE INSIDE THE BODY'S PATIENT AND 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 AND THE PATIENT'S 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 PRIOR TO USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610982 ↗
• MalfunctionJul 16, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC PAPILLARY DILATATION BALLOON (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 HAD ALREADY BEEN 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 22523779 ↗
• MalfunctionJun 24, 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 BEING PREPARED FOR USE IN A PROCEDURE TO BE PERFORMED ON (B)(6) 2025. DURING PREPARATION, 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. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED BEFORE 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 22323174 ↗
• InjuryMay 28, 2025Material Separation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Separation; Use of Device Problem; Difficult to Open or Remove Packaging Material

  THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN (B)(6) 2024. THE EXACT DAY WAS NOT REPORTED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE STRICTURE BY PLACING A METAL STENT. A HURRICANE RX DILATION BALLOON WAS USED TO ACCESS THE STRICTURE BUT UPON BALLOON DILATION, THE PROTECTIVE PLASTIC SLEEVE COVERING THE BALLOON WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. THE PROTECTIVE SLEEVE SHOULD HAVE BEEN REMOVED DURING PRODUCT UNPACKING. THE SLEEVE WAS NOT VISIBLE UNDER FLUOROSCOPY AND THEREFORE, THE INCIDENT WENT UNNOTICED BY THE HEALTHCARE STAFF. WHEN THE STENT PLACEMENT WAS SUBSEQUENTLY ATTEMPTED, THE STRICTURE COULD NOT BE PASSED, AND THE METAL STENT WAS THEREFORE IMPROPERLY POSITIONED. THE METAL STENT WAS REMOVED, AND DILATION WAS PERFORMED WITH A SECOND HURRICANE RX DILATION BALLOON. DURING THE SECOND DILATATION, A SECOND SLEEVE WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. A METAL STENT WAS THEN SUCCESSFULLY PLACE

  Patient problems: Abdominal Pain; Cholangitis; Inflammation; Pancreatitis; Unspecified Infection

  MAUDE report 22093448 ↗
• InjuryMay 28, 2025Material Separation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Separation; Use of Device Problem; Difficult to Open or Remove Packaging Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO HURRICANE RX DILATION BALLOONS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN (B)(6) 2024. THE EXACT DAY WAS NOT REPORTED. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE STRICTURE BY PLACING A METAL STENT. A HURRICANE RX DILATION BALLOON WAS USED TO ACCESS THE STRICTURE BUT UPON BALLOON DILATION, THE PROTECTIVE PLASTIC SLEEVE COVERING THE BALLOON WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. THE PROTECTIVE SLEEVE SHOULD HAVE BEEN REMOVED DURING PRODUCT UNPACKING. THE SLEEVE WAS NOT VISIBLE UNDER FLUOROSCOPY AND THEREFORE, THE INCIDENT WENT UNNOTICED BY THE HEALTHCARE STAFF. WHEN THE STENT PLACEMENT WAS SUBSEQUENTLY ATTEMPTED, THE STRICTURE COULD NOT BE PASSED, AND THE METAL STENT WAS THEREFORE IMPROPERLY POSITIONED. THE METAL STENT WAS REMOVED, AND DILATION WAS PERFORMED WITH A SECOND HURRICANE RX DILATION BALLOON. DURING THE SECOND DILATATION, A SECOND SLEEVE WAS PUSHED INTO THE BILE DUCT BY THE PHYSICIAN. A METAL STENT WAS THEN SUCCESSFULLY

  Patient problems: Abdominal Pain; Cholangitis; Inflammation; Pancreatitis; Unspecified Infection

  MAUDE report 22093447 ↗
• MalfunctionMay 19, 2025Inflation Problem; Material Split, Cut or Torn; Inflation 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 BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT BILE DUCT STENOSIS PERFORMED ON (B)(6) 2025. DURING ERCP, THE PATIENT NEEDED TO USE THE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER FOR INFLATION AND DILATATION DUE TO BILE DUCT STENOSIS AND FOUND THAT THE BALLOON INFLATION HAD NO RESPONSE WHEN USING CONSUMABLES. 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF A BALLOON CIRCUMFERENTIAL TEAR. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048498 ↗
• 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 21976948 ↗
• MalfunctionApr 24, 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 BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE HURRICANE BALLOON RUPTURED DURING DILATION. 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 21902083 ↗
• MalfunctionMar 31, 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 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. 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 21734569 ↗
• MalfunctionMar 31, 2025Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE 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 COMMON HEPATIC DUCT DURING A DILATATION OF THE BILIARY TRACT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AT 6 ATM WHEN DILATATION OF THE BILIARY STENOSIS WAS PERFORMED. THE BALLOON WAS REMOVED, AND A SECOND BALLOON WAS ATTEMPTED TO BE USED BUT ALSO BURST AT 6 ATM. IT WAS REPORTED THAT NO PIECES OF THE BALLOONS DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRD 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734536 ↗
• MalfunctionMar 25, 2025Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  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 IS UNKNOWN. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. 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 LONGITUDINALLY TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687705 ↗