CRE Wireguided M00558460Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729339397), received between Feb 4, 2019 and Feb 20, 2025 — classified as 11 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Open, Classified

   Potential sterile breach of the pouches in which devices are packaged.

   Z-2633-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 8MM AND 9MM APPROPRIATELY, AND WHEN TRYING TO REACH 10MM DIAMETER, IT WOULD NOT MAINTAIN PRESSURE AND IT SELF-DEFLATED. THE PROCEDURE WAS SUCCESSFULLY 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 BALLOON PINHOLE IN THE ESOPHAGUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424971 ↗
• MalfunctionJan 19, 2024Burst 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 WIRE GUIDED DILATATION BALLOON WAS BEING PREPARED FOR USE IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE BALLOON BURST, AND WATER LEAKED OUT. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543996 ↗
• MalfunctionJul 31, 2023Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST DURING THE INITIAL FILL-UP WITH A HYDROSTATIC SOLUTION. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE WIREGUIDED DILATATION BALLOON. 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 17430664 ↗
• MalfunctionJul 31, 2023Burst Container or Vessel; Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST DURING THE INITIAL FILL-UP WITH A HYDROSTATIC SOLUTION. THE SAME PROBLEM OCCURRED WITH THE SECOND CRE WIREGUIDED DILATATION BALLOON. 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 17430661 ↗
• MalfunctionNov 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT 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. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839334 ↗
• MalfunctionNov 21, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BURST. THE CUSTOMER STATED THAT 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. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837743 ↗
• MalfunctionDec 22, 2021Inflation Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED BALLOON WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE. THE ACCOUNT DID NOT HAVE ANOTHER COLONIC BALLOON SO A BIOPSY FORCEPS WAS USED TO PICK AT THE STRICTURE TO OPEN IT UP A BIT. THE PATIENT WILL HAVE TO GO TO THE HOSPITAL TO GET THE STRICTURE DILATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059894 ↗
• MalfunctionDec 6, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE COLON DURING A COLONIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON BURST. 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 12934822 ↗
• MalfunctionMay 20, 2021Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE AMPULLA OF VATER DURING A CRE BALLOON SPHINCTEROPLASTY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT 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 THIS BALLOON HAS A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855909 ↗
• MalfunctionSep 9, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS TESTED, AND IT WAS NOTICED THAT THE BALLOON WAS LEAKING. 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 FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8977281 ↗
• MalfunctionFeb 4, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED 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 THERE WAS A PINHOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN 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 8302108 ↗