CRE Pulmonary M00550350Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729456230), received between May 6, 2019 and Sep 17, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Leak/Splash

  It was reported to Boston Scientific Corporation that a CRE Pulmonary Dilatation Balloon was attempted to be used in the Lung during a Bronchoscopic Dilation procedure for Tracheal stenosis performed on (b)(6) 2026.During the procedure, the pressure of the pump connected to the balloon remained unchanged. Upon removal and testing of the balloon, leakage was identified. A video clip of the complaint device was provided and showed that 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 patients condition at the conclusion of the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808916 ↗
• InjurySep 5, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that a CRE Pulmonary Dilatation Balloon was used in the right lower lobe of the lung during a Bronchial Dilation procedure to treat airway stenosis performed on (b)(6) 2026.During the procedure, it was reported that the balloon portion of the balloon catheter detached from the catheter while inflated. The technician indicates that they had to retrieve the balloon after they removed the catheter with a forceps. The procedure was completed with original 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50625949 ↗
• MalfunctionAug 17, 2026Leak/Splash; Use of Device Problem

  It was reported to Boston Scientific Corporation that a CRE Pulmonary Dilatation Balloon was being prepared to be used in the airway during an electronic bronchoscopic dilatation of trachea procedure for stenosis performed on (b)(6) 2026.During the preparation, the balloon leaked air and water. The procedure was completed with another CRE Pulmonary 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 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 50280336 ↗
• MalfunctionMay 27, 2026Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE PULMONARY ANATOMY (BRONCHI) DURING A BRONCHOSCOPY STENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON PINHOLE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL 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 25308398 ↗
• MalfunctionOct 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 (BSC) THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A BALLOON DILATATION PROCEDURE TO TREAT AIRWAY STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A BALLOON DILATATION WAS PERFORMED TO A PATIENT BECAUSE OF AN AIRWAY STENOSIS. IT WAS REPORTED THAT THE BALLOON BURST IN THE TRACHEA WHEN IT WAS INFLATED AT 5 ATMOSPHERIC PRESSURE AND WITH THE HANDLE SPECIALLY USED BY BOSTON SCIENTIFIC (BSC). NO PIECE 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 AND 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 23280149 ↗
• MalfunctionAug 18, 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 PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE LEFT MAIN BRONCHUS DURING A BRONCHOSCOPIC BALLOON DILATION PROCEDURE TO TREAT BRONCHIAL STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, BRONCHOSCOPIC BALLOON DILATATION WAS PERFORMED 10 MINUTES AFTER ABLATION, AND THE BALLOON BURST WHEN IT WAS FILLED TO ITS MAXIMUM DIAMETER. IT WAS REPORTED THAT NO PIECE 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 22835120 ↗
• MalfunctionAug 18, 2025Burst 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 LEFT UPPER LOBE OF BRONCHUS DURING A BRONCHOSCOPIC BALLOON DILATATION PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON SUDDENLY BURST DURING DILATION. 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. 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 22834395 ↗
• MalfunctionDec 10, 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 BRONCHUS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON LEAKED WATER AND COULD NOT HOLD PRESSURE. A VIDEO CLIP WAS PROVIDED SHOWING THE BALLOON LEAKED THROUGH A PINHOLE. 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20888803 ↗
• MalfunctionJun 7, 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 PULMONARY TRACTS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON HAD A HOLE IN THE MIDDLE OF A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484008 ↗
• MalfunctionNov 15, 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 MAIN AIRWAY DURING AN AIRWAY STENOSIS AND RECANALIZATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON BURST WHEN IT WAS INFLATED TO 13.5 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 18144275 ↗
• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A TRACHEAL DILATION PROCEDURE PERFORMED ON MARCH 28, 2023. DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE LEAKING AND THE DILATION PRESSURE COULD NOT BE REACHED. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806848 ↗
• MalfunctionApr 17, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A CRE PULMONARY BALLOON WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE SECOND USE OF THE BALLOON IN THE PROCEDURE, AS IT WAS BEING USED IN A NON-BSC TRACHEAL SILICON STENT TO RAISE IT BY ONE CENTIMETER, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751979 ↗
• MalfunctionMar 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED FOR A BRONCHIAL STENOSIS DURING A TRANSBRONCHOSCOPIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE DEVICE WAS PLACED AT THE STENOSIS AND WAS ABOUT TO BE INFLATED. HOWEVER, IT WAS FOUND THAT 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 CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574249 ↗
• MalfunctionOct 4, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE BRONCHI DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540964 ↗
• MalfunctionOct 4, 2022Burst 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 TRACHEA DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE WHEN THE BALLOON WAS PLACED IN THE STRICTURE, THE BALLOON BURST WHEN IT REACHED 13.5 MM. 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 15540895 ↗
• MalfunctionSep 15, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY BALLOON WAS USED IN THE MAIN AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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 15432348 ↗
• MalfunctionJan 26, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PULMONARY CRE BALLOON WAS USED DURING AN UNKNOWN TYPE OF PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING AN UNKNOWN TIME OF EVENT, THE DOCTOR REPORTED THAT THE BALLOON WAS PUNCTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13362102 ↗
• MalfunctionAug 12, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A CRE PULMONARY DILATATION CATHETER WAS USED IN THE LEFT MAIN BRONCHUS DURING A TRANSTRACHEAL BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON COULD NOT BE PRESSURIZED. REPORTEDLY, THE BALLOON WAS TAKEN OUT OF THE PATIENT AND TESTED AFTER RE-PRESSURIZATION, AND NOTICED THAT THE TIP OF THE BALLOON WAS LEAKING. 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 12315818 ↗
• MalfunctionApr 22, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE MAIN TRACHEA DURING A DILATION OF MAIN AIRWAY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON HAD A HOLE. 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 9986714 ↗
• MalfunctionMar 17, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED ABOVE THE CARINA AREA DURING A DILATION OF TRACHEA PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841781 ↗
• InjuryMay 6, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE RIGHT MAIN STEM DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON INFLATION, THE BALLOON BURST AT THE RECOMMENDED PRESSURE FOR THE DILATION SIZE. REPORTEDLY, THE BALLOON WAS RETRIEVED WITH BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583047 ↗