CRE™ PRO M00558690Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 08714729797579), received between Jun 15, 2017 and Jul 17, 2026 — classified as 5 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (52 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-2629-2026 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PRODUCTS WERE REPORTED AS DAMAGED UPON RECEIPT BY THE CUSTOMER. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT, AND THE PRODUCT WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851133 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PRODUCTS WERE REPORTED AS DAMAGED UPON RECEIPT BY THE CUSTOMER. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT, AND THE PRODUCT WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850508 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850253 ↗
• MalfunctionJul 16, 2026Tear, Rip or Hole in Device Packaging

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25850248 ↗
• MalfunctionMay 5, 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 A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO A NORMAL PRESSURE, HOWEVER, IT BURST WHILE BEING USED ON THE PATIENT. 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 25089113 ↗
• MalfunctionMar 12, 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 DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THERE WAS A PRESSURE LOSS, AND THE BALLOON COULD NOT BE INFLATED TO 4.5 ATM. 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 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586403 ↗
• MalfunctionFeb 24, 2026Inflation Problem; Nonstandard Device; 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 A DILATATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2026. PRIOR TO THE PROCEDURE, THEY NOTICED A DEFECT AND DECIDED TO TEST IT OUTSIDE, WHERE THEY NOTICED THAT IT WAS NOT INFLATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 TESTED OUTSIDE THE PATIENT DURING PREPARATION. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: BALLOON PINHOLE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434138 ↗
• MalfunctionJan 6, 2026Material 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 TO TREAT A STRICTURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON HAD A HOLE AND WAS LEAKING DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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. 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 23985142 ↗
• MalfunctionDec 16, 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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING A DILATATION IN ESOPHAGUS PROCEDURE TO TREAT STRICTURE/NARROWING PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS UNABLE TO BE INFLATED AND THERE WAS A SMALL HOLE AT THE TIP OF THE BALLOON. 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 23823984 ↗
• MalfunctionDec 9, 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 ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT DIFFICULTY SWALLOWING PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON BURST AS IT WAS BEING FILLED. 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. 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 23763857 ↗
• MalfunctionAug 27, 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 MAIN PAPILLA DURING AN ENDOSCOPIC LITHOTRIPSY OF BILE DUCT STONES PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON RUPTURED. 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 22908951 ↗
• MalfunctionAug 15, 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 ATTEMPTED TO BE USED DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DILATION BALLOON RUPTURED WHEN REACHING 6 ATM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED. 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 22812997 ↗
• MalfunctionAug 5, 2025Inflation Problem; Material Puncture/Hole; Use of Device Problem; Inflation Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A DILATATION PROCEDURE TO TREAT STRICTURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, THE BALLOON HAD A HOLE IN IT AND WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 WOULD NOT INFLATE DURING THE PREPARATION STAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719754 ↗
• MalfunctionApr 30, 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 ESOPHAGUS DURING A DILATATION OF THE ESOPHAGUS PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON BURST AT 5 ATM DURING A DILATATION OF THE DISTAL PEPTIC STENOSIS. 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 21938848 ↗
• MalfunctionApr 18, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; 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 PAPILLA DURING A PAPILLARY DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN TRYING TO INFLATE THE BALLOON, IT DID NOT INFLATE. WHEN IT WAS CHECKED OUTSIDE THE PATIENT IT WAS CONFIRMED THAT THERE WAS A HOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO 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 A BALLOON TORN LONGITUDINAL. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862988 ↗
• MalfunctionFeb 25, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON LEAK. THE PROCEDURE WAS COMPLETED WITH A SECOND CRE PRO 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 DEVICE BALLOON BURST. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464393 ↗
• MalfunctionFeb 11, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device 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 OF ESOPHAGEAL STRICTURES PROCEDURE PERFORMED ON (B)(6) 2025. BEFORE THE PROCEDURE, A HEALTHCARE PROVIDER PREPARED THE BALLOON AND NOTICED THAT THE DESIRED ATM COULD NOT BE ACHIEVED. WHEN THEY PROCEEDED TO INFLATE THE BALLOON WHILE IT WAS IMMERSED IN WATER, THEY FOUND THAT THERE WERE BUBBLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 TESTED OUTSIDE THE PATIENT DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358483 ↗
• MalfunctionJan 21, 2025Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT IS ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATAION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN UPPER ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ATTEMPTING TO DILATE AN ESOPHAGEAL STRICTURE 2 CRE BALLOONS WOULD NOT INFLATE DUE TO SMALL HOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATAION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201304 ↗
• MalfunctionJan 17, 2025Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT IS ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATAION BALLOON WAS ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN UPPER ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN ATTEMPTING TO DILATE AN ESOPHAGEAL STRICTURE 2 CRE BALLOONS WOULD NOT INFLATE DUE TO SMALL HOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATAION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182724 ↗
• MalfunctionDec 3, 2024Burst 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 ATTEMPTED TO BE USED IN THE ESOPHAGUS DURING AN ESOPHAGEAL DILATION PROCEDURE PERFORMED ON (B)(6) 2024. 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. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839096 ↗
• MalfunctionNov 27, 2024Leak/Splash; Leak/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) 2024. DURING THE PROCEDURE, A 12-15MM BALLOON WAS USED AND THE BALLOON WAS ABLE TO BE DILATED BUT COULD NOT SUSTAIN 8 ATM AS IT KEPT LOSING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PRO WIREGUIDED DILATATION BALLOON. 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 20793039 ↗
• MalfunctionOct 8, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATION BALLOON WAS RECEIVED BY THE CUSTOMER ON (B)(6) 2024. PRIOR TO THE PROCEDURE, UPON RECEIPT, IT WAS DISCOVERED THAT THE PACKAGE WAS PUNCTURED. ITEM WAS NO LONGER STERILE AND PRODUCT INSIDE POSSIBLY DAMAGED. THE PRODUCT WAS NOT USED ON A PROCEDURE. THE PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404311 ↗
• MalfunctionSep 16, 2024Burst 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 PYLORUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS INSERTED INTO PYLORUS, INFLATED AT 12 ATM AND THE BALLOON BURST. IT WAS REPORTED THAT NO PIECES 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 20233473 ↗
• MalfunctionJul 8, 2024Burst 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 PAPILLA DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE DILATING THE PAPILLA. THE CUSTOMER REPORTED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697443 ↗
• MalfunctionJul 5, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PRO WIREGUIDED DILATATION BALLOON WAS USED DURING AN UPPER ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN INFLATING THE BALLOON TO 15MM WITH A PRESSURE OF 8 ATM THE BALLOON POPPED. 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 19680923 ↗