CRE™ RX M00558930Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729965480), received between Jun 26, 2019 and Jul 16, 2026 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850516 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850252 ↗
• MalfunctionJun 19, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY 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 25568569 ↗
• MalfunctionMar 5, 2026Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING A STONE REMOVAL PROCEDURE FOR A BILE DUCT STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON COULD NOT BE PROPERLY EXPANDED AND REPORTEDLY RUPTURED. IT WAS REPORTED THAT THE BALLOON BURST AT A PRESSURE/DIAMETER OF 3ATM/10MM. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527452 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR PROCEDURES INVOLVING ONE CRE RX BILIARY DILATATION BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE PERFORMED ON (B)(6) 2025, THE CRE RX TUNNEL (BLACK SHEATH) WAS DETACHED AND STUCK IN THE ENDOSCOPE. SCOPE WAS PUT THROUGH CLEANING PROCESS, AND INCLUDED MANUAL CLEAN, AND AUTO WASHING PROCEDURE. WITHOUT THE TEAM BEING AWARE, THE SCOPE WAS USED ON ANOTHER PROCEDURE ON (B)(6) 2025, STILL NO REALIZATION OF SHEATH INSIDE THE WORKING CHANNEL. THEN THE SCOPE WAS USED IN ANOTHER TWO SEPARATE PROCEDURES ON (B)(6) 2025, IN THE SECOND CASED PERFORMED ON (B)(6) 2025, IT WAS OBSERVED THAT THE BLACK SHEATH COME OUT OF THE BIOPSY PORT ON THE SCOPE WHEN THEY WITHDREW THE FORCEPS BACK INTO THE ENDOSCOPE. IT WAS REPORTED THAT THE RX TUNNEL DID NOT DETACH INSIDE THE PATIENT. THEY HAVE TO TEST THE FIRST PATIENT (SOURCE) TO SEE IF THERE IS ANY FOR BLOOD-BORNE PATHOLOGY (BBP) WHICH COULD HAVE BEEN PASSED ON TO OTHER PATIENTS AT LATER PROCEDURES. THERE WERE NO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311489 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Use of Device Problem; Detachment of Device or Device Component; Entrapment of Device; Use of Device Problem; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR PROCEDURES INVOLVING ONE CRE RX BILIARY DILATATION BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE PERFORMED ON (B)(6) 2025, THE CRE RX TUNNEL (BLACK SHEATH) WAS DETACHED AND STUCK IN THE ENDOSCOPE. SCOPE WAS PUT THROUGH CLEANING PROCESS, AND INCLUDED MANUAL CLEAN, AND AUTO WASHING PROCEDURE. WITHOUT THE TEAM BEING AWARE, THE SCOPE WAS USED ON ANOTHER PROCEDURE ON (B)(6) 2025, STILL NO REALIZATION OF SHEATH INSIDE THE WORKING CHANNEL. THEN THE SCOPE WAS USED IN ANOTHER TWO SEPARATE PROCEDURES ON (B)(6) 2025, IN THE SECOND CASED PERFORMED ON (B)(6) 2025, IT WAS OBSERVED THAT THE BLACK SHEATH COME OUT OF THE BIOPSY PORT ON THE SCOPE WHEN THEY WITHDREW THE FORCEPS BACK INTO THE ENDOSCOPE. IT WAS REPORTED THAT THE RX TUNNEL DID NOT DETACH INSIDE THE PATIENT. THEY HAVE TO TEST THE FIRST PATIENT (SOURCE) TO SEE IF THERE IS ANY FOR BLOOD-BORNE PATHOLOGY (BBP) WHICH COULD HAVE BEEN PASSED ON TO OTHER PATIENTS AT LATER PROCEDURES. THERE WERE NO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311471 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR PROCEDURES INVOLVING ONE CRE RX BILIARY DILATATION BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE PERFORMED ON (B)(6) 2025, THE CRE RX TUNNEL (BLACK SHEATH) WAS DETACHED AND STUCK IN THE ENDOSCOPE. SCOPE WAS PUT THROUGH CLEANING PROCESS, AND INCLUDED MANUAL CLEAN, AND AUTO WASHING PROCEDURE. WITHOUT THE TEAM BEING AWARE, THE SCOPE WAS USED ON ANOTHER PROCEDURE ON (B)(6) 2025, STILL NO REALIZATION OF SHEATH INSIDE THE WORKING CHANNEL. THEN THE SCOPE WAS USED IN ANOTHER TWO SEPARATE PROCEDURES ON (B)(6) 2025, IN THE SECOND CASED PERFORMED ON (B)(6) 2025, IT WAS OBSERVED THAT THE BLACK SHEATH COME OUT OF THE BIOPSY PORT ON THE SCOPE WHEN THEY WITHDREW THE FORCEPS BACK INTO THE ENDOSCOPE. IT WAS REPORTED THAT THE RX TUNNEL DID NOT DETACH INSIDE THE PATIENT. THEY HAVE TO TEST THE FIRST PATIENT (SOURCE) TO SEE IF THERE IS ANY FOR BLOOD-BORNE PATHOLOGY (BBP) WHICH COULD HAVE BEEN PASSED ON TO OTHER PATIENTS AT LATER PROCEDURES. THERE WERE NO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311468 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR PROCEDURES INVOLVING ONE CRE RX BILIARY DILATATION BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE PERFORMED ON (B)(6) 2025, THE CRE RX TUNNEL (BLACK SHEATH) WAS DETACHED AND STUCK IN THE ENDOSCOPE. SCOPE WAS PUT THROUGH CLEANING PROCESS, AND INCLUDED MANUAL CLEAN, AND AUTO WASHING PROCEDURE. WITHOUT THE TEAM BEING AWARE, THE SCOPE WAS USED ON ANOTHER PROCEDURE ON (B)(6) 2025, STILL NO REALIZATION OF SHEATH INSIDE THE WORKING CHANNEL. THEN THE SCOPE WAS USED IN ANOTHER TWO SEPARATE PROCEDURES ON (B)(6) 2025, IN THE SECOND CASED PERFORMED ON (B)(6) 2025, IT WAS OBSERVED THAT THE BLACK SHEATH COME OUT OF THE BIOPSY PORT ON THE SCOPE WHEN THEY WITHDREW THE FORCEPS BACK INTO THE ENDOSCOPE. IT WAS REPORTED THAT THE RX TUNNEL DID NOT DETACH INSIDE THE PATIENT. THEY HAVE TO TEST THE FIRST PATIENT (SOURCE) TO SEE IF THERE IS ANY FOR BLOOD-BORNE PATHOLOGY (BBP) WHICH COULD HAVE BEEN PASSED ON TO OTHER PATIENTS AT LATER PROCEDURES. THERE WERE NO PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311317 ↗
• MalfunctionNov 12, 2024Burst 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 CRE RX DILATATION BALLOON WAS USED IN THE DUODENAL PAPILLA DURING A PAPILLARY DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE ONGOING USE OF THE DEVICE, THE BALLOON RUPTURED AT 3 ATM (10 MM). THE CUSTOMER REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE 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 20669026 ↗
• MalfunctionJun 8, 2022Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON DID NOT HOLD PRESSURE AND THE POPPED ON THE ELEVATOR. 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 14633955 ↗
• MalfunctionMar 9, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. 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 13712142 ↗
• MalfunctionJan 7, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13197486 ↗
• MalfunctionJan 5, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 13168678 ↗
• MalfunctionMar 17, 2021Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A CRE RX BILIARY DILATATION BALLOON WAS USED, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. PERFORMED ON (B)(6) 2021. IT WAS REPORTED, THAT DURING PREPARATION. THE BALLOON WAS TESTED, PRIOR TO USE IN A PROCEDURE. AND IT WAS NOTICED, THAT THE BALLOON WAS LEAKING, DUE TO A SMALL HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE RX BILIARY DILATATION BALLOON. NOTE: THE INSTRUCTIONS FOR USE (IFU), INDICATE THAT THE BALLOON SHOULD NOT BE PRE-INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509398 ↗
• MalfunctionApr 3, 2020Detachment 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 PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AFTER DILATION, IT WAS NOTED THAT THE BLACK RX TUNNEL CAME OFF FROM THE CATHETER INTO THE SCOPE. REPORTEDLY, THE SCOPE TOGETHER WITH THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 Consequences Or Impact To Patient

  MAUDE report 9923176 ↗
• MalfunctionApr 3, 2020Detachment 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 PAPILLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AFTER DILATION, IT WAS NOTED THAT THE BLACK RX TUNNEL CAME OFF FROM THE CATHETER INTO THE SCOPE. REPORTEDLY, THE SCOPE TOGETHER WITH THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 Consequences Or Impact To Patient

  MAUDE report 9923124 ↗
• MalfunctionJun 26, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE RX BILIARY DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE PHYSICIAN WAS PERFORMING SPHINCTEROPLASTY, A SMALL HOLE OPENED IN THE SIDE OF THE BALLOON AND WATER STARTED TO STREAM OUT CAUSING THE BALLOON TO DEFLATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737051 ↗