CRE™ PRO M00558700Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 08714729797586), received between Aug 21, 2017 and Sep 17, 2026 — classified as 6 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (55 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-2630-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Tear, Rip or Hole in Device Packaging

  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 (b)(6) 2026.Prior to the procedure, indents were noted on the device pouch, resulting in a sterile barrier breach.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797731 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850260 ↗
• MalfunctionJun 2, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON EXPLODED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS EXPECTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368106 ↗
• MalfunctionJun 1, 2026Inflation Problem; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PRO WIREGUIDED DILATATION BALLOONS WERE ATTEMPTED TO BE USED DURING A GASTROINTESTINAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS DILATED BUT DID NOT HOLD THE PRESSURE. AFTER INSPECTION, A PUNCTURED WAS OBSERVED AT THE BALLOON BASE. ADDITIONALLY, THE SAME PROBLEM OCCURRED WITH THE OTHER CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THE ANATOMY LOCATION OF THE PROCEDURE 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 AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345588 ↗
• MalfunctionMay 28, 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 GASTROESOPHAGEAL (GE) JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR DYSPHAGIA PERFORMED ON 5 MAY 2026. DURING THE PROCEDURE, THE BALLOON LEAKED AFTER REACHING A DIAMETER OF 16.5MM. ADDITIONALLY, A SMALL PINHOLE WAS NOTICED ON THE PROXIMAL SIDE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL CRE PRO WIREGUIDED DASE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326316 ↗
• MalfunctionMay 16, 2026Inflation Problem; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOONS THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGUS DILATATION PROCEDURE TO TREAT STRICTURES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE LIKE IT SHOULD, THEY USED ANOTHER ONE AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PRO WIREGUIDED DILATATION BALLOON. 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 FULLY RECOVERED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON LONGITUDINALLY TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196048 ↗
• MalfunctionMay 16, 2026Inflation Problem; Material Split, Cut or Torn

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOON THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGUS DILATATION PROCEDURE TO TREAT STRICTURES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE LIKE IT SHOULD, THEY USED ANOTHER ONE AND HAD THE SAME PROBLEM. THE PROCEDURE WAS COMPLETED WITH A THIRD CRE PRO WIREGUIDED DILATATION BALLOON. 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 FULLY RECOVERED. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON LONGITUDINALLY TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196047 ↗
• MalfunctionApr 13, 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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE TECHNICIAN REPORTED THAT THE DEVICE WAS INFLATED CORRECTLY; HOWEVER, THE BALLOON MALFUNCTIONED AND POPPED WHILE BEING USED. 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 24858776 ↗
• MalfunctionApr 8, 2026Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A DILATION PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON HAD A HOLE WHEN INFLATION WAS ATTEMPTED. IT WAS ALSO REPORTED THAT THE BALLOON BURST, AND NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE ANATOMY LOCATION OF THE PROCEDURE WHERE THE PINHOLE OCCURRED 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 24821542 ↗
• MalfunctionApr 7, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR A BILIARY STONE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON POPPED AFTER ONLY ONE USAGE. NO PIECE OF 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 24805316 ↗
• MalfunctionApr 1, 2026Burst Container or Vessel; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  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 TO TREAT ESOPHAGEAL STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE NURSE REPORTED PERFORMING SEQUENTIAL DILATION FROM 15-18 MM UP TO 7 ATM, PER INSTRUCTION FOR USE (IFU). WHILE MAINTAINING INFLATION FOR 60 TO 90 SECONDS, THE BALLOON BROKE. 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 AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758521 ↗
• MalfunctionMar 30, 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 GASTROSCOPY PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6), 2026. DURING PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A HOLE AT THE DISTAL TIP. 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 24737396 ↗
• MalfunctionMar 25, 2026Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE FOR STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, TWO VERY SMALL HOLES WERE FOUND IN THE BALLOON. THE ANATOMY LOCATION OF THE PROCEDURE IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 24691835 ↗
• MalfunctionMar 25, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE THE BALLOON WAS BEING INFLATED, IT BURST INSIDE THE PATIENT. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER CRE PRO 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 24683828 ↗
• MalfunctionMar 20, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. 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 24652017 ↗
• MalfunctionMar 13, 2026Burst Container or Vessel

  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 FOR DILATION PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHEN THE BALLOON WAS INFLATED TO 18 MM, THE BALLOON BURST. IT WAS REPORTED THAT NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595496 ↗
• MalfunctionFeb 27, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CRE PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE ESOPHAGEAL DILATION PROCEDURE, UPON REACHING THE THIRD DILATION LEVEL, THE BALLOON BURST. 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 24470632 ↗
• MalfunctionFeb 24, 2026Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A STRICTURE DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS NOT PRETESTED AS REQUESTED BY THE PHYSICIAN; HOWEVER, IT WAS ADVANCED THROUGH THE BIOPSY CAP AND NAVIGATED THROUGH THE ENTEROSCOPE WORKING CHANNEL WITHOUT DIFFICULTY. THE PROCEDURE PROGRESSED NORMALLY, AND THE BALLOON FUNCTIONED AS INTENDED DURING DILATION. WHEN WITHDRAWAL WAS ATTEMPTED, THE BALLOON COULD NOT BE RETRIEVED THROUGH THE ENTEROSCOPE AND WAS NOTED TO BE DEFORMED. ALL STANDARD TROUBLESHOOTING STEPS WERE PERFORMED TO CONFIRM COMPLETE DEFLATION, BUT REMOVAL THROUGH THE SCOPE REMAINED UNSUCCESSFUL. DESPITE THESE EFFORTS, THE PHYSICIAN CONTINUED TO ENCOUNTER DIFFICULTY RETRIEVING THE CRE CATHETER. ULTIMATELY, THE TIP OF THE BALLOON WAS CUT, ALLOWING SUCCESSFUL REMOVAL OF THE CATHETER FROM THE SCOPE. A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THAT THE BALLOON WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438553 ↗
• MalfunctionFeb 24, 2026Difficult to Remove; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A STRICTURE DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FIRST BALLOON WAS INFLATED AND THEN DEFLATED BY THE INSTRUMENT NURSE; HOWEVER, IT DID NOT FULLY DEFLATE. AS A RESULT, THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE DEVICE THROUGH THE ENTEROSCOPE WORKING CHANNEL, AND NOTABLE RESISTANCE WAS ENCOUNTERED DURING REMOVAL. THE BALLOON WAS ULTIMATELY REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 24438457 ↗
• MalfunctionFeb 13, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATION BALLOON WAS ATTEMPTED TO BE USED DURING A GASTRO PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST BEFORE REACHING THE MAXIMUM INFLATION AMOUNT. IT WAS REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON OF THE SAME MODEL. 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 24339534 ↗
• MalfunctionFeb 11, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE COMMON BILE DUCT DURING A DILATION PROCEDURE TO TREAT COMMON BILE DUCT STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 15 MM AND THEN TO 16.5 MM WITH NO PROBLEMS NOTED. HOWEVER, UPON INFLATION TO 18 MM, 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 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317714 ↗
• MalfunctionJan 27, 2026Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON DID NOT DEFLATE AS EXPECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 24191352 ↗
• MalfunctionJan 26, 2026Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICES WERE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE FOR TREATMENT OF A STRICTURE ON (B)(6) 2025 DURING THE PROCEDURE, THE BALLOON BURST AT 16.5 MM SIZE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT ADDITIONALLY, THE SAME PROBLEM HAPPENED ON THE OTHER CRE PRO WIREGUIDED DILATATION BALLOON DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS PROLONGED AS A RESULT OF THESE EVENTS; HOWEVER, THE AMOUNT OF ADDITIONAL PROCEDURE TIME COULD NOT BE OBTAINED AND WAS REPORTED TO BE UNAVAILABLE BY THE CUSTOMER/ACCOUNT. THERE WERE 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186074 ↗
• MalfunctionJan 26, 2026Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICES WERE USED IN THE ESOPHAGUS DURING A DILATION PROCEDURE FOR TREATMENT OF A STRICTURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AT 16.5 MM SIZE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT ADDITIONALLY, THE SAME PROBLEM HAPPENED ON THE OTHER CRE PRO WIREGUIDED DILATATION BALLOON DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS PROLONGED AS A RESULT OF THESE EVENTS; HOWEVER, THE AMOUNT OF ADDITIONAL PROCEDURE TIME COULD NOT BE OBTAINED AND WAS REPORTED TO BE UNAVAILABLE BY THE CUSTOMER/ACCOUNT. THERE WERE 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186073 ↗
• MalfunctionJan 26, 2026Burst Container or Vessel

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PRO WIREGUIDED DILATATION BALLOON DEVICES WERE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE FOR TREATMENT OF A STRICTURE ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AT 16.5 MM SIZE. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. ADDITIONALLY, THE SAME PROBLEM HAPPENED ON THE OTHER CRE PRO WIREGUIDED DILATATION BALLOON DEVICE. THE PROCEDURE WAS PROLONGED AS A RESULT OF THESE EVENTS; HOWEVER, THE AMOUNT OF ADDITIONAL PROCEDURE TIME COULD NOT BE OBTAINED AND WAS REPORTED TO BE UNAVAILABLE BY THE CUSTOMER/ACCOUNT. THERE WERE 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185404 ↗