CRE Pulmonary M00550330Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729456216), received between Mar 21, 2019 and Sep 8, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Inflation Problem; Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678090 ↗
• MalfunctionJul 28, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BRONCHOSCOPY WITH TRACHEAL DILATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN USING THE DILATION BALLOON, THERE IS A MICRO-LEAK AT THE TIP, CAUSING IT TO DEFLATE. THE HOLE IS NOT VISIBLE BUT BECOMES EVIDENT WHEN INFLATED BECAUSE THE TIP LEAKS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 STABLE. NOTE: A PHOTO WAS PROVIDED BY THE CUSTOMER AND SHOWED THE TIP WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637201 ↗
• MalfunctionJun 11, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS A LEAKAGE OF LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE. ADDITIONAL INFORMATION RECEIVED ON JUNE 12, 2025: IT WAS REPORTED THAT THE BALLOON WAS PRE-INFLATED PRIOR TO USE IN THE PATIENT. 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 22185364 ↗
• MalfunctionJun 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN A PROCEDURE TO TREAT THE AIRWAY PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155639 ↗
• MalfunctionMay 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE TRACHEA DURING A TRACHEAL STENOSIS PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS A LEAKAGE OF FLUID FROM THE FRONT END OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. 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 22111848 ↗
• MalfunctionDec 25, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE BRONCHUS DURING A PULMONARY DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DOCTOR USED THE CRE BALLOON TO DILATE THE STRICTURE INSIDE THE BRONCHUS AND STARTED THE 8MM SIZE FIRST BUT AFTER INFILLED THE SALINE INTO THE BALLOON USING AN ENCORE DEVICE THE BALLOON INFLATED TO 8MM LARGER, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THE REPORTED EVENT MAY SUGGEST A BALLOON BURST OCCURRED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21016456 ↗
• MalfunctionMay 22, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE RIGHT MIDDLE LOBE BRONCHUS AND LEFT LINGUAL SEGMENT BRONCHUS DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER WAS EXAMINED, AND IT WAS FOUND THAT THE BALLOON CONNECTION PART OF THE CATHETER WAS DAMAGED, AND FLUID LEAKED. IT WAS ALSO REPORTED THAT THE PROXIMAL END OF THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374878 ↗
• MalfunctionApr 11, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE LEFT MAIN AIRWAY OF THE LUNG DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED AND WAS LEAKING WATER. THE CUSTOMER REPORTED THAT THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094029 ↗
• MalfunctionFeb 15, 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 PULMONARY DILATATION BALLOON WAS USED IN THE RIGHT PRIMARY BRONCHUS DURING A SUBLARYNGEAL MASK AIRWAY INTERVENTION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON BURST WHEN THE PRESSURE WAS INCREASED TO 9 MM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717826 ↗
• MalfunctionDec 12, 2023Burst Container or Vessel; Use of Device Problem; Material Deformation; Burst Container or Vessel; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LUNG DURING A BALLOON DILATATION FOR A TRACHEAL STENOSIS PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS FOUND TO BE KINKED. THE CUSTOMER REPORTED THAT THE BALLOON BURST WHEN THE DEVICE WAS BROUGHT FROM THE HOSPITAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313501 ↗
• MalfunctionDec 1, 2023Burst 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 PULMONARY DILATATION BALLOON WAS USED IN THE SUPERIOR LOBE OF RIGHT LUNG DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST WHEN PRESSURE WAS APPLIED TO 10 MM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246902 ↗
• MalfunctionNov 30, 2023Burst 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 PULMONARY DILATATION BALLOON WAS USED IN THE SUPERIOR LOBE OF LEFT LUNG DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST WHEN PRESSURE WAS APPLIED TO 9 MM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237663 ↗
• MalfunctionAug 9, 2023Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LEFT PRINCIPAL BRONCHUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE BALLOON WAS NOTICED TO HAVE A LATERAL LEAKAGE WHEN TESTED OUTSIDE THE PATIENT'S BODY. A VIDEO SUBMITTED BY THE CUSTOMER SHOWED A PINHOLE IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 BE STABLE. 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 17490483 ↗
• MalfunctionJun 15, 2023Material Puncture/Hole; Material Perforation; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Material Perforation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOONS WAS USED IN THE BRONCHUS DURING AN INTRATRACHEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING LIQUID AFTER PRESSURE WAS APPLIED AND IT COULD NOT HOLD ENOUGH PRESSURE TO MAINTAIN SUPPORT. IT WAS ALSO NOTED THAT THERE WAS A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140758 ↗
• MalfunctionDec 8, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE WINDPIPE DURING A DILATATION OF WINDPIPE PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON COULD NOT CONTINUE TO RISE AS SALINE WAS FAINTLY OUTFLOWING FROM THE SIDE. THE DEVICE WAS THEN WITHDRAWN FROM THE PATIENT AND A HOLE WAS NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944354 ↗
• MalfunctionJul 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY BALLOON WAS USED IN THE LUNG DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON OF THE CATHETER STARTED TO LOSE PRESSURE AND CONTRAST WAS VISIBLY LEAKING IN TO THE ENDOSCOPIC VIEW. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND ATTEMPTS WERE MADE TO SUCTION AS MUCH CONTRAST OUT OF THE LUNG. A SMALL HOLE WAS NOTED ON THE BALLOON ONCE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114499 ↗
• MalfunctionSep 17, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LUNG DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS LEAKING AND COULDN'T BE INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488991 ↗
• MalfunctionMay 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION CATHETER WAS USED IN THE LEFT PRINCIPAL BRONCHUS DURING A BALLOON DILATATION VIA FIBEROPTIC BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON CATHETER BURST WHILE BEING FILLED WITH LIQUID HALF WAY IN THE LEFT TRACHEA. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874489 ↗
• MalfunctionMar 5, 2021Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A CRE PULMONARY DILATATION CATHETER WAS USED IN THE LARYNX DURING A PROCEDURE PERFORMED ON (B)(6) 2021. THE NARROW AIRWAY TREE WAS DILATED BY ENDOSCOPE, AND THE POSITIONING OF THE BALLOON AT THE NARROW POINT PROVIDED A VISUAL REFERENCE POINT. IT WAS REPORTED THAT WHEN THE LARYNX WAS DILATED BY THE BALLOON DURING TREATMENT, THE BALLOON LEAKED AFTER THE FIRST DILATATION. AN ALLIANCE SYRINGE WAS THEN USED TO DEFLATE THE BALLOON; HOWEVER, A SOUND WAS HEARD FROM THE SYRINGE WHICH FRIGHTENED AND CAUSED ANXIETY TO THE 5-MONTH-OLD PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DEVICE. IN THE PHYSICIAN'S ASSESSMENT, THERE WAS NO SERIOUS INJURY, AND NO TREATMENT WAS NEEDED FOR THE PATIENT EFFECTS. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE. CORRECTION: NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THE CRE PULMONARY IS INTENDED TO ENDOSCOPICALLY DILATE STRICTURES OF THE AIRWAY TREE; HOWEVER, THE BALLOON WAS USED TO DILATE THE LARYNX FOR THIS CASE. ADDITIONAL INFORMATION RECEIVED ON MARCH 14, 2021: IT WAS CLARIFIED THAT THE SOUND HEARD WAS FROM THE ALLIANCE HANDLE, NOT FROM THE ALLIANCE SYRINGE. AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419016 ↗
• MalfunctionMar 21, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LEFT MAIN TRACHEA DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439575 ↗