CRE Pulmonary M00550300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729456186), received between Nov 25, 2019 and Dec 13, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Burst Container or Vessel; Material Integrity Problem; Burst Container or Vessel; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS BEING PREPARED FOR USE IN THE AIRWAY IN A PULMONARY DILATATION PROCEDURE TO BE PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE PACKAGE WAS OPENED IT WAS DISCOVERED 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. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926605 ↗
• MalfunctionSep 28, 2023Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING A DIRECT LARYNOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING INSERTION, THE PHYSICIAN INFLATED THE BALLOON TO TEST IT BEFORE INSERTION INTO THE SCOPE, BUT THE BALLOON BURST AT 4 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL 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 PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839624 ↗
• MalfunctionJun 29, 2022Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE LOWER AIRWAY DURING AN AIRWAY STENOSIS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN UNPACKING AND AFTER INJECTING LIQUID, THE BALLOON BURST AT 8ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. 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. 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 14859176 ↗
• MalfunctionJun 13, 2022Leak/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 USED IN THE AIRWAY DURING A TRACHEAL STENOSIS PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE DISTAL END OF THE BALLOON WAS NOTED TO BE LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATION 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. IT WAS NOTED THAT THE BALLOON HAD BEEN PRE-TESTED PRIOR TO USE IN THE PATIENT. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE NOT TO PRE-INFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681629 ↗
• MalfunctionDec 1, 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 BRONKS DURING A DILATION OF BRONKS PROCEDURE PERFORMED ON (B)(6) 2021. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910107 ↗
• MalfunctionSep 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE AIRWAY DURING A BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BE LEAKING LIQUID. THE PROCEDURE WAS CANCELLED AT THIS TIME. 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 12461526 ↗
• MalfunctionSep 7, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT 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'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436387 ↗
• MalfunctionSep 1, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY BALLOON WAS USED IN A DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS PUNCTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 2, 2021*** THE ANATOMY LOCATION WAS THE RIGHT MIDDLE BRONCHUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407049 ↗
• MalfunctionAug 18, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE BALLOON WAS NOTED TO BREAK DURING INFLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CURRENT CONDITION WAS REPORTED TO BE OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339398 ↗
• MalfunctionDec 1, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY BALLOON WAS USED IN THE AIRWAY DURING A PROCEDURE PERFORMED ON OCTOBER 30, 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. 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. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 2, 2020*** THE DEVICE WAS USED DURING AN AIRWAY DILATION PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10927540 ↗
• MalfunctionOct 12, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY BALLOON WAS USED IN THE LEFT MAIN STEM BRONCHUS DURING A BRONCH DILATION AND STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON POPPED, AND THE PATIENT EXPERIENCED BLEEDING. THE BLEEDING CORRECTED ITSELF VIA NATURAL COAGULATION. NO ADDITIONAL DILATION WAS NEEDED AT THIS POINT. AN ULTRAFLEX AIRWAY STENT WAS THEN SUCCESSFULLY PLACED, AND THE PROCEDURE WAS COMPLETED AT THIS TIME. IN THE PHYSICIANS ASSESSMENT, THE BALLOON POPPING AGGRAVATED THE PATIENTS AIRWAY, CAUSING THE BLEEDING. IT WAS REPORTED THAT THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10667279 ↗
• MalfunctionNov 25, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE DISTAL TRACHEA DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED BETWEEN 13.5 MM TO 15MM STAGE OF INFLATION. IT WAS NOTED THAT IT MIGHT BE CAUSED BY THE GUIDEWIRE USED WITH THE DEVICE. REPORTEDLY, SALINE LEAKED INTO THE LUNGS AND WAS SUCTIONED. THE PATIENT WAS MOVED TO RECOVERY AND 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 AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369549 ↗