CRE PulmonaryRecalls & reported problems across all models

We found 6 models of CRE Pulmonary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 28, 2026 — classified as 3 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (43 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CRE Pulmonary problems

CRE Pulmonary models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CRE Pulmonary M00550340

  BRONCHOSCOPE ACCESSORY
  26 reports
• CRE Pulmonary M00550310

  BRONCHOSCOPE ACCESSORY
  21 reports
• CRE Pulmonary M00550350

  BRONCHOSCOPE ACCESSORY
  21 reports
• CRE Pulmonary M00550330

  BRONCHOSCOPE ACCESSORY
  20 reports
• CRE Pulmonary M00550320

  BRONCHOSCOPE ACCESSORY
  15 reports
• CRE Pulmonary M00550300

  BRONCHOSCOPE ACCESSORY
  12 reports

Recent CRE Pulmonary adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922587 ↗
• MalfunctionSep 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922295 ↗
• MalfunctionSep 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922292 ↗
• 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 ↗
• MalfunctionSep 8, 2026Inflation Problem; Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678090 ↗
• 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 22, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50389931 ↗
• 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 ↗
• MalfunctionApr 10, 2026Inflation Problem; Leak/Splash

  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 BRONCHIECTASIS PROCEDURE FOR STENOSIS PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BALLOON LEAKED LIQUID AND COULD NOT BE INFLATED. 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 24842023 ↗
• MalfunctionMar 6, 2026Material Puncture/Hole; 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 UPPER AIRWAY DURING A MICROLARYNGOSCOPY PROCEDURE FOR DILATION PERFORMED ON (B)(6) 2026. DURING PREPARATION, IT WAS FOUND THAT THERE WAS A PINHOLE IN THE BALLOON. 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 PRE-INFLATED OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24534603 ↗
• MalfunctionFeb 13, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE TRACHEA DURING AN AIRWAY STENOSIS DILATION PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FRONT END OF THE DEVICE WAS OBSERVED TO BE LEAKING WATER. 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 24338864 ↗
• MalfunctionJan 29, 2026Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PRESSURE OF THE DILATOR SYRINGE WAS NOT HOLDING. THE BALLOON WAS TESTED ON THE TABLE AFTER THE PROCEDURE AND A HOLE WAS NOTICED AT THE TIP. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWS THE BALLOON INFLATED OUTSIDE THE PATIENT WITH A PINHOLE LEAK OF LIQUID STREAMING FROM THE DISTAL END OF 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206887 ↗
• MalfunctionJan 15, 2026Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE AIRWAY DURING A BRONCHOSCOPIC DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS LEAKING WATER. 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 24079403 ↗
• MalfunctionDec 30, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN RIGHT MAIN BRONCHUS DURING AN ENDOSCOPIC DILATATION PROCEDURE OF TRACHEA TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, FOLLOWING ABLATION OF THE RIGHT MAIN BRONCHUS, THE BALLOON BURST UNEXPECTEDLY WHEN INFLATED TO 3 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931266 ↗

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