CRE™ RX M00558860Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729965411), received between Dec 29, 2020 and Mar 25, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING THE PROCEDURE, THE BLACK PORTION OF CRE RX BROKE INSIDE OF THE SCOPE. IT WAS REPORTED THAT NO PART OF THE DETACHED PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 21690001 ↗
• InjuryApr 9, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE RX TUNNEL (BLACK SEGMENT OR SHEATH) OF THE DEVICE DETACHED INSIDE THE PATIENT AND STENT DEPLOYMENT COULD NOT BE PERFORMED. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE RX TUNNEL OF THE DEVICE WAS DETACHED. THE DETACHED RX TUNNEL WAS ABLE TO BE REMOVED FROM THE PATIENT USING GRASPERS. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE RX DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE RX DILATATION BALLOON AND THE STENT WAS ABLE TO BE PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076147 ↗
• InjuryApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE RX DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE RX TUNNEL (BLACK SEGMENT OR SHEATH) OF THE DEVICE DETACHED INSIDE THE PATIENT AND STENT DEPLOYMENT COULD NOT BE PERFORMED. A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE RX TUNNEL OF THE DEVICE WAS DETACHED. THE DETACHED RX TUNNEL WAS ABLE TO BE REMOVED FROM THE PATIENT USING GRASPERS. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE RX DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE RX DILATATION BALLOON AND THE STENT WAS ABLE TO BE PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076146 ↗
• MalfunctionMar 23, 2022Entrapment 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 THREE CRE RX DILATATION BALLOONS WERE USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST DEVICE WENT INTO THE SCOPE AND WHEN THEY REMOVED THE DEVICE, THE BLACK PART GOT STUCK AND DETACHED IN THE SCOPE, UNNOTICED. THE ATTEMPTED TO PUT TWO CONSECUTIVE CRE RX INTO THE SCOPE BUT IT COULDN'T PASS THE SCOPE BECAUSE AT THE TIME THEY DID NOT REALIZE THAT THE BLACK PIECE FROM THE FIRST DEVICE WAS STILL STUCK IN THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A CRE WIREGUIDED BALLOON INSTEAD. AFTER THE PROCEDURE WAS COMPLETED, THEY REALIZED THAT THE BLACK PIECE WAS STILL IN THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870204 ↗
• MalfunctionMay 10, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE LEAK AND DID NOT PROPERLY INFLATE. 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 11803651 ↗
• MalfunctionMar 8, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH LUMINAL DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SEEMED BROKEN FROM THE TIME AN ATTEMPT TO INFLATE WAS MADE. REPORTEDLY, THE BALLOON INFLATE OR HOLD THE CONTRAST. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MARCH 9, 2021. IT WAS REPORTED THAT THE BALLOON DID NOT BURST, HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD A SMALL LEAK AND WOULD NOT HOLD PRESSURE. THE PROCEDURE WAS PERFORMED IN THE COMMON BILE DUCT (CBD) AND DUODENUM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436700 ↗
• MalfunctionDec 29, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BALLOON WAS USED IN THE PAPILLA VATERI DURING A DILATATION ASSISTED STONE EXTRACTION (DASE) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX 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 GOOD. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087314 ↗