CRE™ RX M00558920Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729965473), received between Nov 14, 2019 and Mar 31, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE BILE DUCT DURING A CHOLANGOIOSCOPY PROCEDURE TO TREAT JAUNDICE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, TWO SCIVITA SCOPES WERE USED; HOWEVER, NEITHER PROVIDED AN IMAGE OR SIGNAL ON THE MONITOR. A LARGER SCIVITA SCOPE WAS THEN USED, BUT IT WAS TOO LARGE TO ACCESS THE BILE DUCT. AS A RESULT, THE PHYSICIAN PERFORMED A BALLOON SPHINCTEROPLASTY, WHICH LED TO MAJOR HEMORRHAGE. THE BLEEDING WAS MANAGED WITH AN ADRENALINE INJECTION AND PLACEMENT OF A FULLY COVERED METAL STENT. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED PANCREATITIS. DUE TO THESE EVENTS, THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS REPORTED TO HAVE RECOVERED AFTER EMBOLIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis

  MAUDE report 24748832 ↗
• MalfunctionJan 22, 2026Inflation Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BALLOON INFLATION WAS OBSERVED TO BE WEAK. UPON REMOVAL AND SUBSEQUENT TABLE TESTING, LEAKAGE WAS DETECTED AT THE DISTAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON DEVICE. THE TYPE OF PROCEDURE AND THE ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN AND ARE BEING REPORTED AS THE BALLOON LEAK 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 24152569 ↗
• InjuryNov 5, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE DILATION, THE PHYSICIAN NOTICED THAT THE BLACK SHEATH PRESENT ON A PORTION OF THE CATHETER REMAINED INSIDE THE PATIENT, SPECIFICALLY WITHIN THE WIRSUNG DUCT. IT WAS REPORTED THAT THE DETACHED PIECE INSIDE THE PATIENT WAS RETRIEVED USING AN EXTRACTION BALLOON AND A GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. *** CORRECTION*** NOTE: IT WAS REPORTED THAT THE DEVICE WAS USED IN THE PANCREAS HOWEVER, ACCORDING TO THE IFU: THE CRE RX BILIARY BALLOON DILATATION CATHETERS ARE INDICATED FOR USE IN ADULTS FOR ENDOSCOPIC DILATATION OF THE SPHINCTER OF ODDI WITH OR WITHOUT PRIOR SPHINCTEROTOMY. THE CRE RX BILIARY BALLOON DILATATION CATHETERS MAY BE USED FOR INJECTION OF CONTRAST MEDIUM FOR FLUOROSCOPIC VISUALIZATION OF THE BILE DUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473152 ↗
• MalfunctionOct 31, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON HAD A HOLE, AND WATER LEAKED OUT WHEN PRESSURE WAS APPLIED. SINCE IT WAS USED AT 8 MM AND THE LEAK WAS MINIMAL, IT WAS CONTINUOUSLY USED AS IT IS. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE TYPE OF PROCEDURE AND THE ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN AND ARE BEING REPORTED AS THE PINHOLE 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 23442412 ↗
• MalfunctionJun 2, 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 CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLA DISSECTION PROCEDURE TO TREAT COMMON BILE DUCT STONE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ATTEMPTING TO DILATE THE PAPILLA WITH THE DEVICE, THERE WAS A LEAK FROM THE BALLOON. A PINHOLE-LIKE HOLE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 22125561 ↗
• InjuryMay 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON RUPTURED WHEN THE PAPILLA WAS DILATED, CAUSING BILIARY BLEEDING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY THROUGH HEMOSTASIS WITH SELF-EXPANDABLE METALLIC STENT (SEMS). ON A LATER DATE, BLEEDING WAS CONFIRMED AGAIN AND LED TO OPERATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22013640 ↗
• MalfunctionJan 10, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC BILIARY STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON SIZE IMMEDIATELY DECREASED, AFTER PRESSURIZING AND INFLATING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST THAT THE BALLOON BURST DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21128747 ↗
• MalfunctionSep 12, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THIS DEVICE WAS INSERTED THROUGH THE FORCEPS CHANNEL AND DILATED TO ABOUT 1 ATM, THE LIQUID INSIDE THE BALLOON LEAKED OUT AND IT COULD NOT BE DILATED. ACCORDING TO THE COMPLAINANT, IT SEEMS THAT THE BALLOON RUPTURED OR HAD ADHESIVE DEFECTS FROM THE START SINCE THERE WAS NO RESISTANCE WHEN IT WAS INSERTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207839 ↗
• InjuryJun 10, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A GUIDEWIRE WAS USED TO CANNULATE THE AMPULLA AND PERFORM A SPHINCTEROTOMY. THE AMPULLA WAS DILATED WITH A CRE RX DILATATION BALLOON. ANOTHER (DIFFERENT MODEL) BALLOON WAS PASSED ONTO THE GUIDEWIRE AND INTO THE DUCT BUT WAS UNABLE TO INFLATE. THE BALLOON WAS REMOVED AND CHECKED OUTSIDE OF THE PATIENT AND WAS ABLE TO INFLATE. UPON REINTRODUCTION OF THE BALLOON AND ADVANCEMENT DOWN THE SCOPE, A BLACK PLASTIC TUBE (RX TUNNEL FROM THE CRE RX DILATATION BALLOON) WAS NOTICED ON THE GUIDEWIRE. A SECOND GUIDEWIRE WAS PLACED, THE ORIGINAL GUIDEWIRE WAS RETRIEVED CAUSING THE RX TUNNEL TO BE PUSHED INTO THE DUODENUM OF THE PATIENT. THE DETACHED RX TUNNEL WAS RETRIEVED USING A SNARE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505241 ↗
• MalfunctionApr 16, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATATION (EPBD) PROCEDURE PERFORMED FOR THE TREATMENT OF COMMON BILE DUCT STONE ON (B)(6) 2024. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DILATE THE PAPILLA BY PERFORMING INFLATION, THE BALLOON RUPTURED, AND THE DILATION COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 19122315 ↗
• MalfunctionMar 19, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6)2024. DURING THE PROCEDURE, THE RX TUNNEL (BLACK SEGMENT OR SHEATH ON THE DISTAL CATHETER) DETACHED INTO THE CHANNEL OF THE SCOPE. THE CUSTOMER WAS ABLE TO PUSH IT OUT OF THE SCOPE AND REPORTED THAT NOTHING WAS DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 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 18938322 ↗
• InjuryJun 28, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY 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 INITIALLY POPPED IN THE BILE DUCT. HOWEVER, DURING THE REMOVAL OF THE CATHETHER, THE ENTIRE CATHETER THAT HOUSES THE BALLOON AREA CAME OFF. REPORTEDLY, THE DETACHED PORTION OF THE CATHETER WAS UNABLE TO BE RETRIEVED AFTER MULTIPLE ATTEMPTS USING FORCEPS, SNARE, GRASPERS, BALLOONS, EXTRACTOR BALLOONS AND BASKETS, EVENTUALLY THE DETACHED PORTION WAS LEFT IN THE PATIENT. THE PATIENT WAS CLOSELY MONITORED AFTER THE PLACEMENT OF BILIARY PLASTIC STENT. ACCORDING TO THE ORIGINAL REPORTER THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12079019 ↗
• MalfunctionJun 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY 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 BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066220 ↗
• InjuryMar 25, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE BALLOON CATHETER WAS DIFFICULT TO REMOVE FROM THE WORKING CHANNEL BY THE PHYSICIAN AND THE TECH. AFTER PULLING THE DEVICE FROM THE SCOPE, IT WAS FOUND THAT THE BLACK RX TUNNEL AND THE DISTAL PART OF THE BALLOON DETACHED AND WERE STUCK IN THE SCOPE. THE BALLOON WAS ACCIDENTALLY PUSHED INTO THE CBD OF THE PATIENT AND WAS RETRIEVED WITH AN EXTRACTOR BALLOON AND RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED 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 11567846 ↗
• MalfunctionNov 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BLACK RX TUNNEL OF THE DEVICE DETACHED FROM THE CATHETER INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322336 ↗