CRE Pulmonary M00550310Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729456193), received between Mar 11, 2019 and Sep 28, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 21 most recent of 21 reports, 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 50922292 ↗
• MalfunctionAug 22, 2026Burst Container or Vessel

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50389931 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 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 LUNGS AND ESOPHAGUS DURING A PULMONARY BALLOON DILATATION OF CRICOPHARYNGEUS AND ESOPHAGOSCOPY PROCEDURE TO TREAT DYSPHAGIA PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BALLOON WAS ABLE TO BE INFLATED TO 3 ATM BUT WHEN IT WAS INFLATED TO 7 ATM THE BALLOON DEFLATED. IT WAS REPORTED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931010 ↗
• MalfunctionOct 17, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; 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 BALLOON DILATATION OF THE AIRWAY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, LARYNGEAL MASK ANESTHESIA WAS USED DURING EXCISION OF THE TRACHEAL LESION AND PERFORM BALLOON DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS FOUND TO BE LEAKING. IT WAS REPORTED THAT WATER WAS INJECTED WITH A SYRINGE FOR PRESSURIZATION. DESPITE THE EXCESSIVE INJECTION VOLUME, THE PRESSURE GAUGE FAILED TO MAINTAIN STABILITY AT THE FIRST-LEVEL PRESSURE. THE OPERATOR WITHDREW THE BALLOON FROM THE STENOTIC SITE, OBSERVED THE BALLOON WAS LEAKING, AND THEN IDENTIFIED THE BALLOON RUPTURED. NO PIECE OF THE BALLOON DETACHED INSIDE THE PATIENT. DUE TO THE PROBLEM OF THE BALLOON DILATATION STEP, THE PHYSICIAN SWITCHED TO USING A BIOPSY FORCEPS TO RESECT THE HYPERPLASTIC TISSUE, THEREBY WIDENING THE AIRWAY AND COMPLETED THE PROCEDURE. THE CHANGE IN SURGICAL APPROACH HAS RESULTED IN THE PROLONGATION OF THE OPERATION TIME AND WAS ESTIMATED TO BE EXTENDED BY 30 MINUTES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323859 ↗
• MalfunctionSep 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 THROAT DURING A TRACHEOSCOPY WITH BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LEAK WAS NOTICED IN THE CRE BALLOON DURING INFLATION. 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 23186964 ↗
• MalfunctionSep 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE TRACHEA DURING AN AIRWAY STENOSIS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS REPORTED THAT A LEAK WAS NOTED ON THE FRONT OF THE DEVICE. 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 23092795 ↗
• MalfunctionNov 21, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE SUBGLOTTIC DURING AN ENDOSCOPIC DILATATION OF TRACHEA PROCEDURE PERFORMED ON NOVEMBER 3, 2023. DURING THE PROCEDURE, THE BALLOON WAS LEAKING SALINE INTO THE PATIENT'S LUNGS. THE BALLOON WAS THEN INSPECTED, AND A SMALL HOLE WAS NOTED. 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 18185532 ↗
• MalfunctionJun 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN TRACHEAL Y-TYPE SILICONE STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO INFLATE, IT WAS FOUND LEAKING LIQUID. 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 17192780 ↗
• MalfunctionApr 17, 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 BALLOON WAS USED IN THE TRACHEA DURING A TRACHEA BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE WHEN THE PHYSICIAN DILATED THE STENOSIS OF TRACHEA, THE SURFACE OF THE BALLOON WAS BROKEN, RESULTING IN LIQUID BEING SPRAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY 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. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON APRIL 20, 2023, IT WAS REPORTED THAT THE BALLOON BURST AT 3 ATM. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753496 ↗
• MalfunctionFeb 15, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PULMONARY DILATATION BALLOONS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381066 ↗
• MalfunctionFeb 13, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PULMONARY DILATATION BALLOONS WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16369173 ↗
• MalfunctionNov 22, 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 MAIN AIRWAY DURING A BALLOON DILATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BALLOON REACHED THE STENOSIS IN THE MAIN AIRWAY, BUT BURST WHEN THEY APPLIED PRESSURE. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 15846032 ↗
• MalfunctionMar 16, 2022Material 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 LUNG DURING AN AIRWAY BALLOON DILATION PROCEDURE PERFORMED ON (B)(6). 2022. DURING THE PREPARATION, IT WAS NOTICED THAT THE TIP OF THE BALLOON HAD A PINHOLE LEAK. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13783799 ↗
• MalfunctionNov 1, 2021Burst 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 BALLOON WAS USED IN THE INFERIOR VENA CAVA DURING AN ANGIOPLASTY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 3 ATM TO PREDILATE THE STENOSIS AND WAS THEN DEFLATED AND REMOVED FROM THE PATIENT. THE BALLOON WAS POSITIONED AND INFLATED AT 6 ATM TO POSTDILATE THE STENT; HOWEVER, AFTER 1 MINUTE IT WAS NOTICED THAT THE BALLOON DECREASED IN PRESSURE AND A MIXTURE OF BLOOD AND CONTRAST MEDIUM REFLOW INTO THE INSUFLATOR. ADDITIONALLY, A RUPTURE WAS NOTED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 INFERIOR VENA CAVA FOR THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12732077 ↗
• MalfunctionJun 2, 2021Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PULMONARY DILATATION BALLOONS WERE USED IN THE RIGHT MAIN STEM OF THE BRONCHUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN ATTEMPTING TO ADVANCE THE BALLOON DOWN THE WORKING CHANNEL AND INTO POSITION THE TIP KEPT BENDING. THE BALLOON WAS UNABLE TO PASS INTO POSITION BETWEEN THE MALIGNANCY. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS RE-INFLATED FOR INSPECTION. THE BALLOON SEEMED FINE UNTIL IT WAS PASSED BACK DOWN THE SCOPE AND THE TIP CONTINUED TO BEND. A SECOND CRE PULMONARY DILATATION BALLOON WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON DEVICE. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THE BALLOON SHOULD NOT BE PRE-INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919047 ↗
• MalfunctionJun 2, 2021Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE PULMONARY DILATATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CRE PULMONARY DILATATION BALLOONS WERE USED IN THE RIGHT MAIN STEM OF THE BRONCHUS DURING A DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN ATTEMPTING TO ADVANCE THE BALLOON DOWN THE WORKING CHANNEL AND INTO POSITION THE TIP KEPT BENDING. THE BALLOON WAS UNABLE TO PASS INTO POSITION BETWEEN THE MALIGNANCY. THE DEVICE WAS REMOVED FROM THE PATIENT AND WAS RE-INFLATED FOR INSPECTION. THE BALLOON SEEMED FINE UNTIL IT WAS PASSED BACK DOWN THE SCOPE AND THE TIP CONTINUED TO BEND. A SECOND CRE PULMONARY DILATATION BALLOON WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON DEVICE. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THE BALLOON SHOULD NOT BE PRE-INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11919045 ↗
• MalfunctionMar 3, 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 TRACHEA DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED TWICE TO 7ATM. HOWEVER, THE BALLOON RUPTURED AND DEFLATED. IT WAS NOTED THAT THE PRESSURE AT THE TIME OF THE BURST WAS GREATER THAN 7ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408063 ↗
• MalfunctionJun 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE END OF THE DEVICE WAS FLAT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663326 ↗
• MalfunctionMar 11, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS USED DURING AN AIRWAY DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON . THERE HAVE BEEN 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 Consequences Or Impact To Patient

  MAUDE report 8409459 ↗