CRE™ PRO M00558650Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 08714729797531), received between Aug 31, 2018 and Sep 22, 2026 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (22 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Inflation Problem; Leak/Splash

  It was reported to Boston Scientific Corporation that a CRE PRO Wireguided Dilatation Balloon was attempted to be used during a procedure performed on (b)(6) 2026.During the procedure, it was reported that the customer was unable to inflate the balloon as there was fluid coming out and was leaking. The procedure was completed with another of the same device. The anatomy location of the procedure is unknown and is being reported as the balloon leak may have occurred in the esophagus.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855057 ↗
• MalfunctionJun 19, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON STARTED LEAKING DURING DILATION. 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 25559010 ↗
• MalfunctionJun 6, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE TYPE OF PROCEDURE AND THE ANATOMY LOCATION OF THE PROCEDURE ARE UNKNOWN, AND IT IS BEING REPORTED AS THE BALLOON LEAK MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 25420585 ↗
• MalfunctionApr 20, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, IT WAS NOTICED THAT THE BALLOON LEAKED WATER WHEN INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 24933922 ↗
• MalfunctionApr 3, 2026Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE TO TREAT ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS ADVANCED THROUGH THE GASTROSCOPE. WHEN THE USER ATTEMPTED TO INFLATE THE BALLOON, IT DID NOT INFLATE DUE TO A VISIBLE SPLIT IN THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. HERE 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 24778261 ↗
• MalfunctionApr 2, 2026Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR ESOPHAGEAL STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE DILATION PROCEDURE, THE BALLOON KEPT DEFLATING. UPON REMOVAL FROM THE PATIENT, THE BALLOON WAS TESTED AND A PINHOLE WATER LEAK WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 24772409 ↗
• MalfunctionApr 2, 2026Inflation Problem; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE FOR ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER INFLATION ATTEMPT, THE MEDIUM WAS LEAKING FROM THE BALLOON, CREATING INFLATION ISSUES. 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 24767744 ↗
• MalfunctionMar 31, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, BUT IT DID NOT EXPAND. AFTER REMOVING THE BALLOON CATHETER FROM THE SCOPE, A HOLE WAS OBSERVED IN THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THE ANATOMY LOCATION AND PROCEDURE TYPE ARE UNKNOWN AND IS BEING REPORTED AS THE PINHOLE MAY HAVE OCCURRED IN THE ESOPHAGUS THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750297 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE MEDIAL TRACT OF THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE FOR A BENIGN STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON DETACHED AWAY FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. A PHOTO OF THE DEVICE WAS PROVIDED AND SHOWS THE DISTAL PORTION OF THE BALLOON IS DETACHED. 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 FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24564987 ↗
• MalfunctionJan 29, 2026Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATION OF ESOPHAGUS PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DILATOR BALLOON WAS INFLATED AND FOUND TO HAVE A HOLE, CAUSING WATER TO LEAK INTO THE PATIENT STOMACH. THE PATIENT WAS SUCTIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY FIVE MINUTES DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216067 ↗
• MalfunctionJan 20, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE DUODENAL BULB DESCENDING JUNCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT THE CHOLANGITIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DILATION BALLOON WAS ADVANCED ALONG THE GUIDEWIRE TO GRADUALLY DILATE THE STENOSIS. IT WAS REPORTED THAT THE BALLOON BURST AT 5 ATM, BUT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. AFTER THE BALLOON WAS BURST, THE PATIENT GASTRIC MUCOSA WAS TORN, RESULTING IN BLEEDING. THE BLEEDING WAS TREATED WITH FASTING, HEMOSTATIC DRUGS, SOMATOSTATIN, AND OTHER CONSERVATIVE MEASURES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 24127256 ↗
• MalfunctionDec 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY PROCEDURE TO TREAT A STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 23931007 ↗
• MalfunctionDec 29, 2025Burst 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 PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN INFLATING THE DEVICE AT 6 ATM, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON WAS DETACHED AND FELL INSIDE THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JANUARY 12, 2026. THE TYPE OF PROCEDURE PERFORMED WAS GASTROSCOPY WITH DILATATION FOR ESOPHAGEAL STRICTURE TREATMENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME CRE PRO WIREGUIDED DILATATION BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914210 ↗
• MalfunctionDec 18, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THERE WAS A HOLE IN THE BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845770 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THEY INFLATED THE BALLOON, AND WATER WAS LEAKING OUT. THE BALLOON WAS REMOVED FROM THE PATIENT, AND A BALLOON LEAK WAS OBSERVED. TWO ADDITIONAL CRE PRO WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED BUT ALSO LEAKED DURING USE. THE PROCEDURE WAS COMPLETED WITH A FOURTH CRE PRO WIREGUIDED DILATATION BALLOON. THE ANATOMY LOCATION DURING THE LEAK 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. 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 23813333 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THEY INFLATED THE BALLOON, AND WATER WAS LEAKING OUT. THE BALLOON WAS REMOVED FROM THE PATIENT, AND A BALLOON LEAK WAS OBSERVED. TWO ADDITIONAL CRE PRO WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED BUT ALSO LEAKED DURING USE. THE PROCEDURE WAS COMPLETED WITH A FOURTH CRE PRO WIREGUIDED DILATATION BALLOON. THE ANATOMY LOCATION DURING THE LEAK 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. 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 23813332 ↗
• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THEY INFLATED THE BALLOON, AND WATER WAS LEAKING OUT. THE BALLOON WAS REMOVED FROM THE PATIENT, AND A BALLOON LEAK WAS OBSERVED. TWO ADDITIONAL CRE PRO WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED BUT ALSO LEAKED DURING USE. THE PROCEDURE WAS COMPLETED WITH A FOURTH CRE PRO WIREGUIDED DILATATION BALLOON. THE ANATOMY LOCATION DURING THE LEAK 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. 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 23813330 ↗
• MalfunctionNov 25, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON BURST WHEN DILATATION WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650179 ↗
• MalfunctionNov 25, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON BURST WHEN DILATATION WAS PERFORMED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650177 ↗
• MalfunctionOct 23, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING ESOPHAGEAL DILATION PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CRE WAS INSERTED DOWN THE SCOPE WORKING CHANNEL TO THE STRICTURE SITE. A CRE STERIFLATE WAS USED TO ATTEMPT TO INFLATE THE BALLOON, HOWEVER IT DID NOT INFLATE. THERE APPEARED TO BE A SMALL HOLE WHERE THE INFLATION WATER WAS LEAKING OUT FROM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 23368634 ↗
• MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE LUNGS DURING A PULMONOSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON (B)(6) 2025. DURING THE PROCEDURE, WHILE DILATING, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 23057283 ↗
• MalfunctionAug 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT SWALLOWING DIFFICULTIES PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE BALLOON WAS INTRODUCED THROUGH THE ENDOSCOPE FOR THE INITIAL INFLATION, THE BALLOON BEGAN TO EXPAND NORMALLY BUT THEN TECHNICIAN FELT A SUBTLE LOSS OF PRESSURE, BUT NO POP. WHEN THE BALLOON WAS DEFLATED VERY LITTLE WATER RETURNED TO THE SYRINGE. THE PHYSICIAN OPTED TO PROCEED WITHOUT SWITCHING TO A NEW BALLOON. THE SYRINGE WAS REFILLED TO 35ML AND THE BALLOON REINFLATED, BUT THE BALLOON WAS ONLY ABLE TO INFLATE TO 19MM. POST PROCEDURE, AFTER DEFLATION AND REMOVAL OF THE BALLOON THROUGH THE WORKING CHANNEL, ONLY ABOUT 25ML OF WATER WAS WITHDRAWN INTO THE SYRINGE WHEN THE BALLOON WAS FULLY DEFLATED. THE DEVICE WAS INSPECTED AND IDENTIFIED A SMALL PUNCTURE NEAR THE DISTAL END OF THE BALLOON, CLOSE TO THE AREA WHERE THE GUIDEWIRE PASSES THROUGH. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920048 ↗
• MalfunctionAug 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THEY NOTICED SEVERAL HOLES ON THE BALLOON. A PHOTO OF THE COMPLAINT DEVICE INSIDE THE PATIENT WAS PROVIDED AND SHOWED THAT THE BALLOON WAS LEAKING THROUGH SEVERAL PINHOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 22862994 ↗
• MalfunctionAug 21, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AMPULLA DURING AN AMPULLA DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. 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 CRE PRO 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 22862140 ↗
• MalfunctionAug 5, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THEY NOTICED A LEAK/WATER SHOOTING OUT OF IT. THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 22721847 ↗