CRE™ PRO M00558710Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 08714729797593), received between Nov 5, 2018 and Sep 5, 2026 — classified as 5 injuries, 279 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (119 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-2631-2026 · Root cause: Package design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50626422 ↗
• MalfunctionSep 5, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50626421 ↗
• MalfunctionSep 2, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575973 ↗
• MalfunctionSep 1, 2026Burst Container or Vessel; Difficult to Advance

  It was reported to Boston Scientific Corporation (BSC) that a CRE PRO Wireguided DASE Dilatation Balloon was attempted to be used in the esophagus during an esophageal stricture procedure performed on (b)(6) 2026.During the procedure, resistance was encountered when threading the balloon through the working channel of the scope. Upon inflation with the syringe assembly, the balloon burst inside the patients esophagus. The customer stated that no pieces of the balloon detached inside the patient. The procedure was completed with another CRE PRO Wireguided DASE Dilatation Balloon of a different lot number and a non-BSC inflation device.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 stable.Additional Information received 03 SEP 2026.Patient was having an Esophagogastroduodenoscopy (EGD) Dilation and a CRE Pro Wireguided dilator measurements 18-20mm was used. Instrument appeared intact, all checks completed. The balloon was inflated as normal, but the balloon burst while in the patient's esophagus at the max pressure. No injury to the patient, however, a new instrument had to be used d

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550084 ↗
• MalfunctionAug 18, 2026Burst Container or Vessel; Inflation Problem; Material Puncture/Hole

  Note: This report pertains to one of two CRE PRO Wire guided Dilatation Balloons used in the same patient and procedure.It was reported to Boston Scientific Corporation that two CRE PRO Wire guided Dilatation Balloons were attempted to be used during a procedure performed on (b)(6) 2026.During the procedure, the balloon would not inflate due to a hole. Additionally, the same problem occurred with the other CRE PRO Wire guided Dilatation Balloon. The procedure was completed using another CRE PRO Wire guided Dilatation Balloon. There were no patient complications reported as a result of this event and the patient condition following procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293541 ↗
• MalfunctionAug 16, 2026Inflation Problem; Material 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 performed on (b)(6) 2026.During the procedure, the balloon would not inflate due to a pinhole. The type of procedure and the anatomy location of the procedure are unknown, and it is being reported as the pinhole 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 50266620 ↗
• MalfunctionJul 29, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071735 ↗
• MalfunctionJul 28, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056051 ↗
• MalfunctionJul 22, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905513 ↗
• MalfunctionJul 16, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841780 ↗
• MalfunctionJul 11, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT A BALLOON LEAKED WAS NOTICED WHEN THE BALLOON INFLATED INSIDE THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25790166 ↗
• MalfunctionJul 9, 2026Leak/Splash

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A GASTROSCOPY WITH DILATATION PROCEDURE FOR ESOPHAGEAL STRICTURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, AFTER THE BALLOON WAS INTRODUCED THROUGH THE WORKING CHANNEL, THE FIRST TWO DILATION STAGES (18MM AND 19MM) WERE PERFORMED WITHOUT ANY DIFFICULTIES. DURING THE THIRD DILATION STAGE (20 MM), THE BALLOON WAS NO LONGER ABLE TO MAINTAIN THE FLUID DUE TO A POSSIBLE LEAK IN THE DEVICE. THE BALLOON WAS REMOVED AND A SECOND OF THE SAME BALLOON DEVICE WAS ATTEMPTED TO BE USED. HOWEVER, THE SAME PROBLEM OCCURRED WITH THE SECOND BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD CRE PRO WIREGUIDED DASE DILATATION BALLOON. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE AND 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 25767011 ↗
• MalfunctionJul 8, 2026Burst Container or Vessel; Adverse Event Without Identified Device or Use Problem

  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 ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE BALLOON WAS PASSED DOWN SCOPE, THE BALLOON BURST AFTER REACHING A DIAMETER OF 20MM. NO PIECE OF BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DASE. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25756432 ↗
• MalfunctionJul 2, 2026

  "BALLOON WOULD NOT HOLD PRESSURE AT 6 ATM DURING DILATION TO 20MM DIAMETER. THEREFORE, NOT BEING ABLE TO DILATE AT 20MM. BALLOON REMOVED AND NEW ONE USED WITHOUT INCIDENCE. BALLOON SEQUESTERED AND GIVEN TO [REDACTED] FOR FOLLOW UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689826 ↗
• MalfunctionJun 24, 2026Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 25603855 ↗
• MalfunctionJun 22, 2026Inflation Problem; Leak/Splash; Use of Device Problem

  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 DASE DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR DILATATION PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE BALLOON EXHIBITED SMALL BUBBLES AND FAILED TO FULLY INFLATE. TROUBLESHOOTING CONSISTED OF ATTEMPTING TO INFLATE TWO ADDITIONAL BALLOONS FROM THE SAME LOT, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH DEVICE OF THE SAME TYPE. 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. 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 25587804 ↗
• MalfunctionJun 22, 2026Inflation Problem; Leak/Splash; Use of Device Problem

  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 DASE DILATATION BALLOON WAS BEING PREPARED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR DILATATION PERFORMED ON (B)(6) 2026. DURING PREPARATION, THE BALLOON EXHIBITED SMALL BUBBLES AND FAILED TO FULLY INFLATE. TROUBLESHOOTING CONSISTED OF ATTEMPTING TO INFLATE TWO ADDITIONAL BALLOONS FROM THE SAME LOT, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A FOURTH DEVICE OF THE SAME TYPE. 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. 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 25587767 ↗
• MalfunctionJun 17, 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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN INSTRUCTED INFLATION OF THE BALLOON TO 18 MM, WHICH WAS PERFORMED WITHOUT RESISTANCE. THE PHYSICIAN THEN DIRECTED FURTHER INFLATION TO 20 MM. WHILE SLOWLY INFLATING PAST 19 MM AND APPROACHING 20 MM, THE BALLOON RUPTURED. THE PROBLEM WAS SIGNIFICANT THAT THE BALLOON MATERIAL SPLIT, RESULTING IN AN IMMEDIATE LOSS OF FLUID AND PRESSURE. THE CUSTOMER STATED THAT NO PIECES 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 25536376 ↗
• MalfunctionJun 9, 2026Burst Container or Vessel; Leak/Splash

  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 DILATION PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, BALLOON POPPED DURING INFLATION AND WOULD NOT HOLD PRESSURE. THE SAME PROBLEM WAS ALSO ENCOUNTERED WITH THE SECOND CRE PRO WIREGUIDED DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON DEVICE. 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 25446021 ↗
• MalfunctionJun 8, 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 AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE FOR STRICTURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AFTER THE BALLOON REACHED 18MM, A LEAK WAS NOTICED AND 5ML OF WATER WENT INTO THE PATIENT ESOPHAGUS. THE PROCEDURE WAS DISCONTINUED BY THE PHYSICIAN AND CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE RESCHEDULED PROCEDURE DATE REMAINS UNKNOWN DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435621 ↗
• MalfunctionJun 4, 2026Leak/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, THE BALLOON EXHIBITED A SIGNIFICANT LEAK DURING USE, PREVENTING IT FROM MAINTAINING INFLATION PRESSURE. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED. THE EXACT ANATOMY LOCATION AND TYPE OF PROCEDURE WHEN THE BALLOON LEAK WAS ENCOUNTERED IS UNKNOWN AND IS BEING REPORTED AS IT MAY HAVE OCCURRED IN THE ESOPHAGUS. 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 25399458 ↗
• 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 25345595 ↗
• MalfunctionMay 31, 2026Burst Container or Vessel; Inflation Problem

  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 THE PROCEDURE, WHEN THE BALLOON WAS INFLATED, THE STAFF HEARD A POPPED SOUND, AND THE BALLOON DID NOT STAY INFLATED. IT WAS REPORTED THAT NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342786 ↗
• MalfunctionMay 28, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DASE DILATATION BALLOON WAS ATTEMPTED TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON LEAKAGE ON THE INITIAL FLUID WAS NOTICED. 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 A DIFFERENT DEVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316917 ↗
• MalfunctionMay 25, 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 AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT ESOPHAGEAL DILATION PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PINHOLE LEAK AT THE PROXIMAL END OF THE BALLOON. 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 25271725 ↗