CRE Wireguided M00558430Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729339366), received between Nov 28, 2018 and Aug 22, 2024 — classified as 10 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. 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.

• MalfunctionAug 22, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST AT 15 ATM WHILE IT WAS BEING INFLATED INSIDE THE PATIENT. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043847 ↗
• MalfunctionApr 16, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT THE BALLOON WAS NOT OVERINFLATED, AND NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122347 ↗
• MalfunctionFeb 21, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 BURST. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755004 ↗
• MalfunctionMar 28, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHILE THE TECHNICIAN WAS INFLATING THE DEVICE, THE BALLOON RUPTURED AT 4.5 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630361 ↗
• MalfunctionMar 8, 2023Difficult to Remove; Use of Device Problem; Material Twisted/Bent; Difficult to Remove; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE WITHDRAWAL, THE BALLOON WAS UNABLE TO BE PULLED THROUGH THE SCOPE. THE PHYSICIAN CUT THE BALLOON FOR REMOVAL FROM THE SCOPE AND NOTICED THE DISTAL END OF THE BALLOON TIP WAS BENT. THE PHYSICIAN NOTED THAT THE BALLOON WAS NOT ADEQUATELY DEFLATED WHEN IT WAS BEING PULLED THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL 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 FINE. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THIS BALLOON SHOULD BE COMPLETELY DEFLATED PRIOR TO REMOVING THE DEVICE FROM THE SCOPE. HOWEVER, THE CUSTOMER REPORTED THAT THE BALLOON WAS NOT COMPLETELY DEFLATED DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507359 ↗
• MalfunctionJan 14, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A LEAK WAS NOTED AT THE PROXIMAL SECTION OF THE BALLOON DUE TO A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED 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. 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 9587688 ↗
• MalfunctionAug 5, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIRE GUIDED DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE MAJOR DUODENAL PAPILLA ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING UPON INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIRE GUIDED 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. INVESTIGATION RESULTS REVEALED THAT THE BALLOON WAS BURST; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861598 ↗
• MalfunctionDec 3, 2018Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE AND THE EXIT MARKER BUNCHED UP; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125276 ↗
• MalfunctionNov 28, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON LEAKED WHEN THE PHYSICIAN TRIED TO IMPLANT THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON BURST; THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111252 ↗
• MalfunctionNov 28, 2018Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE AND THE EXIT MARKER WAS BUNCHED-UP. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111249 ↗