CRE Wireguided M00558500Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 08714729339434), received between Nov 5, 2018 and Sep 28, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (19 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

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

   Z-2637-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925875 ↗
• MalfunctionSep 22, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859316 ↗
• MalfunctionSep 9, 2026Burst Container or Vessel; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700515 ↗
• MalfunctionMay 15, 2026Material 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 FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A PINHOLE WAS NOTICED IN THE BALLOON. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194160 ↗
• MalfunctionMay 15, 2026Material 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 FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A PINHOLE WAS NOTICED IN THE BALLOON. 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 FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194157 ↗
• MalfunctionMay 8, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN INFLATION WAS ATTEMPTED INSIDE THE PATIENT, THE BALLOON WOULD NOT INFLATE DUE TO A PINHOLE THAT PRODUCES LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND 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 25129000 ↗
• MalfunctionMay 8, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN INFLATING THE BALLOON WITH STERIFLATE THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON WAS DETACHED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND 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 25124180 ↗
• MalfunctionApr 27, 2026Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON DID NOT COMPLETELY FILL DURING DILATION DUE TO A HOLE IDENTIFIED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THE EXACT ANATOMY LOCATION WHEN THE BALLOON PINHOLE WAS ENCOUNTERED IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009165 ↗
• MalfunctionApr 17, 2026Inflation Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WOULD NOT HOLD WATER AND CONTINUED TO LEAK. THE EXACT ANATOMY LOCATION WHEN THE BALLOON LEAK WAS ENCOUNTERED IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 24906462 ↗
• MalfunctionApr 13, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862610 ↗
• MalfunctionFeb 20, 2026Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE DILATION BALLOON WAS ADVANCED THROUGH THE SCOPE; HOWEVER, WHEN INFLATION WAS ATTEMPTED, THE BALLOON DID NOT INFLATE. NO ADDITIONAL BALLOON DEVICES WERE AVAILABLE ON CONSIGNMENT, AND THE PROCEDURE WAS SUBSEQUENTLY CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401743 ↗
• MalfunctionFeb 17, 2026Material 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 TO TREAT A STRICTURE ON (B)(6) 2026. DURING THE PROCEDURE, A HOLE WAS OBSERVED AT THE PROXIMAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER CRE WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372796 ↗
• MalfunctionFeb 17, 2026

  ESOPHAGEAL BALLOON DILATOR RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364150 ↗
• MalfunctionFeb 13, 2026Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED TO 19 MM; HOWEVER, WHEN IT WAS INFLATED TO 20 MM, THE BALLOON COULD NOT BE INFLATED. IT WAS REPORTED THAT THE BALLOON POPPED AND NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331961 ↗
• MalfunctionFeb 6, 2026Connection Problem; Failure to Deflate

  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 TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE NURSE REPORTED THAT THE CONNECTION WAS NOT PROPERLY SECURED, AND AS A RESULT, THE BALLOON WOULD NOT DEFLATE ENOUGH TO EXIT THE SCOPE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED SHOWS THE DEVICE HUB/LUER TYPE CONNECTOR AND THE INFLATION PORT, HOWEVER, NO VISIBLE DAMAGE CAN BE OBSERVED RELATED TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE WIREGUIDED DILATATION BALLOON DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULL RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278334 ↗
• MalfunctionJan 29, 2026Inflation Problem; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR TREATMENT OF AN ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST CRE WIREGUIDED DILATATION BALLOON WAS INFLATED TO 18MM (3ATM) WITHOUT PROBLEM AND SUBSEQUENTLY TO 20MM (6ATM) AS INTENDED. AFTER REPOSITIONING, THE BALLOON WAS REINFLATED TO 20MM, AT WHICH TIME THE CLINICIAN OBSERVED THAT THE BALLOON BEGAN LEAKING AND WAS UNABLE TO MAINTAIN PRESSURE. THE DEVICE WAS REMOVED. A SECOND CRE WIREGUIDED DILATATION BALLOON WAS THEN INTRODUCED AND INFLATED TO 20MM (6ATM). UPON INFLATION, THIS BALLOON IMMEDIATELY LEAKED AND SIMILARLY COULD NOT MAINTAIN PRESSURE, REQUIRING REMOVAL. 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 FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218013 ↗
• MalfunctionJan 29, 2026Inflation Problem; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE WIREGUIDED DILATATION BALLOONS USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR TREATMENT OF AN ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST CRE WIREGUIDED DILATATION BALLOON WAS INFLATED TO 18MM (3ATM) WITHOUT PROBLEM AND SUBSEQUENTLY TO 20MM (6ATM) AS INTENDED. AFTER REPOSITIONING, THE BALLOON WAS REINFLATED TO 20MM, AT WHICH TIME THE CLINICIAN OBSERVED THAT THE BALLOON BEGAN LEAKING AND WAS UNABLE TO MAINTAIN PRESSURE. THE DEVICE WAS REMOVED. A SECOND CRE WIREGUIDED DILATATION BALLOON WAS THEN INTRODUCED AND INFLATED TO 20MM (6ATM). UPON INFLATION, THIS BALLOON IMMEDIATELY LEAKED AND SIMILARLY COULD NOT MAINTAIN PRESSURE, REQUIRING REMOVAL. 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 FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218007 ↗
• MalfunctionDec 30, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  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) WITH DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN INFLATING THE BALLOON LEAKS WERE OBSERVED. A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE BALLOON WITH MULTIPLE PINHOLE LEAKS. 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924128 ↗
• MalfunctionDec 2, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  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 TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS NOT STAYING INFLATED. TOOK OUT OF THE PATIENT AND TESTED AND IT WAS OBSERVED THAT THE WATER WAS LEAKING OUT OF THE BALLOON. IT WAS REPORTED THAT THE BALLOON LEAK AT 18 MM AND 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701352 ↗
• MalfunctionNov 26, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS INTENDED FOR USE IN TREATING A STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, A HOLE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659003 ↗
• MalfunctionSep 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE TECHNICIAN BEGAN INFLATING THE BALLOON AND THEY COULD SEE THE LEAK ON THE SCREEN. IT WAS REPORTED THAT THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23187025 ↗
• MalfunctionJul 23, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED IN THE THROAT DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CRE BALLOON POPPED, AND WATER LEAKED OUT WHILE DILATING. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22583244 ↗
• MalfunctionJul 16, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE CRE BALLOON POPPED AND WATER LEAKED OUT WHILE DILATING. 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 22525346 ↗
• MalfunctionMay 28, 2025Material Puncture/Hole; 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 A DILATION PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE THE TECHNICIAN WAS INFLATING THE BALLOON TO 18 MM WITH WATER, IT WAS NOTED THAT THE BALLOON WAS LEAKING IN THE ENDOSCOPIC VIEW DUE TO A HOLE IN THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT, AND ANOTHER CRE WIREGUIDED DILATATION BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22101751 ↗
• MalfunctionMay 14, 2025Leak/Splash; Leak/Splash

  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, WHEN THE BALLOON WAS INFLATED, IT WAS NOT ABLE TO MAINTAIN PRESSURE AND APPEARED TO LEAK. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS STERIFLATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019577 ↗