Hurricane RXRecalls & reported problems across all models

We found 8 models of Hurricane RX by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,117 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2017 and Sep 28, 2026 — classified as 1 death, 59 injuries, 1,057 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (526 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Hurricane RX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. Oct 21, 2021Open, Classified

   Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

   Z-0324-2022 · Root cause: Device Design · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. Oct 21, 2021Open, Classified

   Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

   Z-0322-2022 · Root cause: Device Design · Recall details · FDA record ↗

7. 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 ↗

8. Oct 21, 2021Open, Classified

   Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

   Z-0320-2022 · Root cause: Device Design · Recall details · FDA record ↗

9. 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 · names 8 of these models · Recall details · FDA record ↗

Most reported Hurricane RX problems

Hurricane RX models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Hurricane™ RX M00545900

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls1 death705 reports
• Hurricane™ RX M00545920

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls211 reports
• Hurricane™ RX M00545940

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls109 reports
• Hurricane™ RX M00545960

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls59 reports
• Hurricane™ RX M00545890

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls28 reports
• Hurricane™ RX M00545910

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls2 reports
• Hurricane™ RX M00545930

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls2 reports
• Hurricane™ RX M00545950

  CATHETER, BILIARY, DIAGNOSTIC
  2 recalls1 report

Recent Hurricane RX adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionSep 3, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600069 ↗
• 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 ↗
• 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 ↗
• 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 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 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 ↗
• 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 ↗
• 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 ↗

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