Hurricane™ RX M00545940Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 08714729283850), received between Feb 26, 2018 and Sep 3, 2026 — classified as 9 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (47 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-0325-2022 · 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600069 ↗
• MalfunctionMay 21, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR PANCREATITIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE DUCT OVER THE GUIDEWIRE. THE BALLOON WAS INFLATED AND MAINTAINED FOR A FEW SECONDS. SUBSEQUENTLY, THE BALLOON BURST. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243910 ↗
• MalfunctionApr 24, 2026Burst 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) WITH DILATION PROCEDURE FOR BILIARY STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON EXPLODED. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. 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 24990452 ↗
• MalfunctionFeb 9, 2026Burst 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 INTRAHEPATIC DUCT DURING A BILE DUCT DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. 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. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD NOT BE PRE-INFLATED PRIOR TO USE IN THE PROCEDURE. HOWEVER, PER THE EVENT, IT WAS REPORTED THAT THE BALLOON WAS PRE-INFLATED PRIOR TO USE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291732 ↗
• MalfunctionDec 18, 2025Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Burst Container or Vessel; 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 USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED, AND THE PHYSICIAN FELT A POP AND THE BALLOON COULD NOT STAY INFLATED. THE DEVICE WAS THEN REMOVED FROM THE SCOPE, AND IT WAS FOUND THAT THE BALLOON WAS SHEARED OFF THE CATHETER. IT WAS REPORTED THAT NO PIECE OF THE BALLOON WAS DETACHED AND FELL INTO THE PATIENT. 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 23844746 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Failure to Deflate; Detachment of Device or Device Component; Failure to Deflate

  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 A TIGHT BILIARY STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO FULLY DEFLATE, AND THE BALLOON SHEARED OFF. THE PHYSICIAN TRIED BALLOON EXTRACTION USING GRASPING FORCEPS BUT WAS UNABLE TO RETRIEVE THE DEFLATED BALLOON FROM THE DUCT. THE PATIENT WAS STENTED PAST THE BALLOON AS PLANNED AT THE START OF THE PROCEDURE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE BALLOON REMAINED IN THE PATIENT, AND THE PATIENT WAS GIVEN POST PROCEDURE ANTIBIOTICS IN RECOVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23709033 ↗
• MalfunctionNov 14, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE BILE DUCT DURING A CHOLEDOCHOLITHOTOMY PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE DUODENAL PAPILLA USING THE DEVICE. IT WAS REPORTED THAT THE BALLOON DID NOT EXPAND TO THE INTENDED DILATION PRESSURE. THE DEVICE WAS REMOVED AND INSPECTED AND FOUND OUT THAT THE BALLOON HAD RUPTURED. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23551509 ↗
• MalfunctionSep 10, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT CHOLANGITIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS TORN DURING THE SECOND INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 TESTED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022707 ↗
• 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 IN THE COMMON BILE DUCT (CBD) 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 22974138 ↗
• 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 IN THE COMMON BILE DUCT (CBD) 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 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 22973880 ↗
• MalfunctionSep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS TORN. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED AND FELL INTO THE PATIENT. 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 22968175 ↗
• MalfunctionSep 3, 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, LEAKAGE WAS NOTED NEAR THE BASE OF THE BALLOON WHEN INFLATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HURRICANE RX DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE ANATOMY LOCATION OF THE PROCEDURE AND TYPE OF PROCEDURE ARE UNKNOWN AND ARE BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960060 ↗
• 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 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524432 ↗
• MalfunctionJun 19, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEFLATED AFTER DILATION AND THE DOCTOR HAD TO PULL QUITE HARD TO REMOVE THE BALLOON FROM THE BILE DUCTS. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED AN INFLATED BALLOON, AND THE GAUGE NEEDLE WAS AT 0 ATM. 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 22293631 ↗
• InjuryJun 12, 2025Break; Detachment of Device or Device Component; Failure to Deflate; Break; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS USED IN THE BILE DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE WIRE WAS SUCCESSFULLY POSITIONED IN THE RIGHT BILE DUCT, ALLOWING THE PLACEMENT OF A HURRICANE DILATION BALLOON TO EXPAND THE STENOSIS AT THE HILUM. HOWEVER, AFTER INFLATION, THE BALLOON FAILED TO DEFLATE AND REMAINED INFLATED. ATTEMPTS TO MOBILIZE IT LED TO THE SHEATH BREAKING, LEAVING THE BALLOON TRAPPED IN THE RIGHT BILE DUCT. EFFORTS TO RETRIEVE IT USING PEDIATRIC FORCEPS WERE UNSUCCESSFUL. THE DOCTOR THEN OPTED TO COMPLETE THE PROCEDURE BY PLACING A HEPATIC GASTRIC TUBE IN THE LIVER AND A METAL STENT AT THE LOWER BILE DUCTS, HOPING TO LATER ACCESS IT VIA A SPYSCOPE. HOWEVER, IN THE FOLLOWING DAYS, THE TUMOR'S PROGRESSION TO THE BILE DUCTS LED TO A WORSENING OF THE PATIENT'S CONDITION, NECESSITATING PALLIATIVE CARE. THE PLANNED SPYGLASS PROCEDURE ON (B)(6) 2025 TO RECOVER THE BALLOON WAS ULTIMATELY CANCELED. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND WAS SENT FOR PALLIATIVE CARE. THE PATIENT DIED ON (B)(6) 2025, DUE TO HIS C

  Patient problems: Foreign Body In Patient

  MAUDE report 22199893 ↗
• InjuryMay 30, 2025Detachment 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 BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BROKE OFF INSIDE PATIENT'S BILE DUCT. IT WAS REPORTED THAT THE BROKEN BALLOON WAS SUCCESSFULLY RETRIEVED USING AN UNKNOWN DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111819 ↗
• MalfunctionMay 13, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HURRICANE RX DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, A CUT WAS NOTED ON THE DEVICE POUCH. IT WAS REPORTED THAT THE STERILE BARRIER OF THE PACKAGING WAS COMPROMISED. 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 22012479 ↗
• 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 (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 THE ORIGINAL 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 OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976368 ↗
• 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 (CBD) DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH THE ORIGINAL 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976247 ↗
• MalfunctionMay 7, 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 COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) STONE RETRIEVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST WHEN THE PHYSICIAN INFLATES THE BALLOON. 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 21976136 ↗
• InjuryMay 6, 2025Break; 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) 2025. DURING THE PROCEDURE, THE BALLOON AND CATHETER DETACHED IN THE PATIENT'S BILE DUCT. ATTEMPTED TO REMOVE THE BROKEN BALLOON FLOATING IN DUCT USING SWEEP TECHNIQUE WITH 12-15, 15-18 STONE EXTRACTION BALLOONS, RIGHT ANGLE FORCEPS, RAT TOOTH FORCEPS AND BASKET; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN ENDED THE PROCEDURE AFTER SEVERAL ATTEMPTS OF RETRIEVAL AND PLACED A COVERED METAL STENT TO GUARANTEE DRAINAGE WITH BROKEN BALLOON STILL IN DUCT. IT WAS REPORTED THAT THE PATIENT WILL BE BROUGHT BACK FOR SECOND ERCP TO UTILIZE SPYGLASS TO ATTEMPT RETRIEVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21972156 ↗
• InjuryApr 3, 2025Detachment 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK SHEATH (RX TUNNEL) DETACHED INSIDE THE PATIENT. A GRASPER WAS USED TO RETRIEVE THE RX TUNNEL FROM WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 21766743 ↗
• MalfunctionMar 5, 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 ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED THROUGH VIABIL, AND WAS ABLE TO BE INFLATED ONCE, WHILE FILLING IT THE SECOND TIME, THE BALLOON BURST AROUND 2-3ATM. THE SAME PROBLEM OCCURRED WITH THE SECOND HURRICANE RX DILATATION BALLOON. IT WAS REPORTED THERE WAS VIABIL STENT IN THE DUCT AND NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529841 ↗
• MalfunctionDec 31, 2024Break; Use of Device Problem; Break; Use of Device Problem

  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) 2024. DURING THE PROCEDURE, THE BALLOON CATHETER BROKE OFF, LEAVING THE BALLOON STUCK IN THE PATIENT'S COMMON BILE DUCT (CBD). IT WAS REPORTED THAT THE BALLOON WAS BEING USED OFF-LABEL IN ATTEMPTS TO DILATE THE CBD AND REMOVE A MIGRATED PLASTIC STENT. IT WAS REPORTED THAT BALLOON AND PART OF THE CATHETER, INCLUDING VISIBLE RADIOPAQUE MARKERS, HAD BROKEN OFF AND WAS LODGED IN THE CBD. THE BALLOON HAS BEEN LEFT IN THE PATIENT, WHO WAS NOT SCHEDULED FOR REMOVAL OR SURGERY DUE TO THEIR OVERALL HEALTH CONDITION. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO KNOWN COMPLICATIONS AT THE TIME IT WAS REPORTED BUT THE DEVICE REMAINED STUCK IN THE PATIENT. THE PATIENT WAS ADMITTED TO PALLIATIVE CARE FOR THEIR TERMINAL CONDITION AND HAS PASSED AWAY. ACCORDING TO THE PHYSICIAN'S ASSESSMENT, THERE WAS NO RELATIONSHIP BETWEEN THE MALFUNCTION OF THE HURRICANE BALLOON AND THE PATIENT'

  Patient problems: Foreign Body In Patient

  MAUDE report 21048713 ↗
• MalfunctionDec 31, 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 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047453 ↗