CRE Fixed Wire M00558330Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729201984), received between Feb 3, 2020 and Apr 21, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING AN UNKNOWN TIME OF EVENT, THE BALLOON BURST AFTER REACHING A PRESSURE OF 10ATM. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE OUTCOME REMAINS UNKNOWN DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD BE USED IN THE ESOPHAGUS ANATOMY LOCATION. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS USED IN THE AMPULLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942008 ↗
• MalfunctionSep 17, 2025Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Burst Container or Vessel; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT DUODENAL PAPILLA STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, STENOSIS OF THE DUODENAL PAPILLA WAS PERFORMED AND THE BALLON BURST WHEN DILATED AT 6 ATM OR 7MM. 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 AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. CORRECTION NOTED ON SEPTEMBER 15, 2025 NOTE: THE INSTRUCTION FOR USE (IFU) STATES THAT THE CRE FIXED WIRE BALLOON DILATATION CATHETERS ARE INDICATED FOR USE IN ADULT AND ADOLESCENT POPULATIONS TO ENDOSCOPICALLY DILATE STRICTURES OF THE ESOPHAGUS. HOWEVER, THE COMPLAINANT REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE WAS AT THE DUODENUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080737 ↗
• MalfunctionMay 6, 2025Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS BEING PREPARED FOR USE IN AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, THE BALLOON CATHETER WAS TESTED BEFORE USE. THE BALLOON BURST IN THE FACE OF THE OPERATOR AND PROJECTED A MIXTURE OF CONTRAST AND SALINE WHEN THE PRESSURE EXERTED WAS 5 ATM. THE OPERATOR WAS TREATED FOR EYE IRRITATION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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: Skin Inflammation/ Irritation

  MAUDE report 21972102 ↗
• MalfunctionMay 24, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS USED FOR DILATION; HOWEVER, IT WAS FOUND THAT THE PUMP WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO FIXED WIRE DILATATION BALLOON 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 16999057 ↗
• MalfunctionMay 19, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS FOUND TO BE FRACTURED AFTER GIVING THE PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER A CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON MAY 21, 2023: THE CUSTOMER STATED THAT THE BALLOON BURST AND NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970049 ↗
• MalfunctionJun 10, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE FIXED WIRE DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE FIXED WIRE DILATATION BALLOONS WERE USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH BALLOONS BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11974391 ↗
• MalfunctionJun 10, 2021Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE FIXED WIRE DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE FIXED WIRE DILATATION BALLOONS WERE USED IN THE ESOPHAGUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH BALLOONS BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11974296 ↗
• MalfunctionMay 14, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST DURING CANNULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827616 ↗
• MalfunctionMar 2, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING AN ESOPHAGODILATATION PROCEDURE PERFORMED IN THE ESOPHAGUS ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A CRACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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 9774999 ↗
• MalfunctionFeb 3, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE DAMAGED DURING THE INFLATION IN THE ESOPHAGUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE 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 9662247 ↗