ALAIR™ M005ATS25010Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 08714729802792), received between Jan 9, 2017 and Jun 6, 2023 — classified as 86 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P080032); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BT CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2023. AFTER THE PROCEDURE, OF A THIRD APPLICATION WHEN THE PATIENT RETURNED HOME, THE PATIENT FELT MORE PAIN AND SHE HAD MORE DIFFICULTY BREATHING. SHE FELT THE NEED TO CONSULT THE EMERGENCY ROOM. AFTER THE FIRST ENDOSCOPY EXAMINATION, EDEMA, NECROSIS, AND A SERIOUS BURN WAS OBSERVED IN THE BRONCHI. IT WAS REPORTED THAT DEBRIDEMENT WAS USED TO PUT OUT SOME BLACK TISSUE THAT BURNED. THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Burn(s); Necrosis; Pain; Respiratory Insufficiency; Swelling/ Edema

  MAUDE report 17070453 ↗
• MalfunctionAug 17, 2022Device Alarm System; Adverse Event Without Identified Device or Use Problem; Activation Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem; Activation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-04603 AND 3005099803-2022-04673 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED FOR SEVERE ASTHMA DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, TWO CATHETERS AND THREE GROUNDING PADS WERE USED. AN ERROR ON THE CONTROLLER SHOWED A PROBLEM WITH THE GROUNDING PAD AND CATHETER. THE PHYSICIAN WAS ABLE TO CONFIRM THAT THE GROUNDING PADS WERE PLACED CORRECTLY AND WAS MAKING CONTACT WITH THE AIRWAY WALL. THE PHYSICIAN REPLACED THE GROUNDING PAD AND CATHETER BUT THE SAME PROBLEM OCCURRED. THEY TESTED THE CONTROLLER WITH MULTIPLE DEMO CATHETERS AND RECEIVED THE SAME ERROR. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243168 ↗
• MalfunctionAug 17, 2022Device Alarm System; Adverse Event Without Identified Device or Use Problem; Activation Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem; Activation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-04602, 3005099803-2022-04603 AND 3005099803-2022-04673 FOR THE ASSOCIATED DEVICE INFORMATION.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CATHETER WAS USED FOR SEVERE ASTHMA DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2022.DURING THE PROCEDURE, TWO CATHETERS AND THREE GROUNDING PADS WERE USED. AN ERROR ON THE CONTROLLER SHOWED A PROBLEM WITH THE GROUNDING PAD AND CATHETER. THE PHYSICIAN WAS ABLE TO CONFIRM THAT THE GROUNDING PADS WERE PLACED CORRECTLY AND WAS MAKING CONTACT WITH THE AIRWAY WALL. THE PHYSICIAN REPLACED THE GROUNDING PAD AND CATHETER BUT THE SAME PROBLEM OCCURRED. THEY TESTED THE CONTROLLER WITH MULTIPLE DEMO CATHETERS AND RECEIVED THE SAME ERROR. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242946 ↗
• MalfunctionMar 16, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE BRONCHUS ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE DISTAL TIP OF THE CATHETER FRACTURED AFTER THE CATHETER WAS PLACED. REPORTEDLY, NO PART OF THE CATHETER DETACHED OR WAS SEPARATED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ALAIR BT CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT ONE ELECTRODE IN THE ARRAY WAS FOUND BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836282 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CONTROLLER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 THE PATIENT DEVELOPED LOWER RESPIRATORY TRACT INFECTION THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE LOWER RESPIRATORY TRACT INFECTION. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S LOWER RESPIRATORY TRACT INFECTION WAS NOT REPORTED. IT WAS NOT NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. ON (B)(6) 2019 THE PATIENT RECOVERED FROM LOWER RESPIRATORY TRACT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9130369 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BREATHING DIFFICULTY (DYSPNEA) REQUIRING UNKNOWN MEDICATION TO TREAT AND HOSPITALIZATION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT EXPERIENCED BREATHING DIFFICULTY AND WAS PRESENTED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS TREATED WITH SYSTEMIC STEROIDS AND AN ADDITIONAL MEDICATION. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S BREATHING DIFFICULTY WAS NOT REPORTED. IT WAS NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. THE EXACT DATES THE PATIENT WAS HOSPITALIZED AND DISC

  Patient problems: Dyspnea

  MAUDE report 9119936 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BREATHING DIFFICULTY (DYSPNEA) REQUIRING UNKNOWN MEDICATION TO TREAT AND HOSPITALIZATION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 THE PATIENT EXPERIENCED BREATHING DIFFICULTY THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE PATIENT'S DYSPNEA. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S BREATHING DIFFICULTY WAS NOT REPORTED. IT WAS NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. THE EXACT DATES THE PATIENT WAS HOSPITALIZED AND DISCHARGED WERE NOT REPORTED. ON (B)(6) 2019 THE PAT

  Patient problems: Dyspnea

  MAUDE report 9118606 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS THAT WAS TREATED WITH SYSTEMIC STEROIDS. IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. REPORTEDLY, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER). THE NUMBER OF TIMES AND DATES THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER) WERE NOT REPORTED. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS.

  Patient problems: No Code Available

  MAUDE report 9118583 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA REQUIRING HOSPITALIZATION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED ASTHMA THAT WAS TREATED WITH SYSTEMIC STEROIDS. IT WAS NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. THE EXACT DATES THE PATIENT WAS HOSPITALIZED AND DISCHARGED WERE NOT REPORTED. ON (B)(6) 2018 THE PATIENT RECOVERED FROM ASTHMA.

  Patient problems: Asthma

  MAUDE report 9118546 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO TREATMENT WAS PERFORMED AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 9118454 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO TREATMENT WAS PERFORMED AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 9118368 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS REQUIRING UNKNOWN MEDICATION TO TREAT. THIS COMPLAINT IS ALSO BEING REPORTED BASED ON THE EVENTS OF ASTHMA ON (B)(6) 2018 AND (B)(6) 2018 REQUIRING UNKNOWN MEDICATION TO TREAT AND PATIENT HOSPITALIZATIONS. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE PERIBRONCHIOLITIS. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S PERIBRONCHIOLITIS WAS NOT REPORTED. IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIO

  Patient problems: Asthma; No Code Available

  MAUDE report 9105787 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHIAL PERITIS REQUIRING UNKNOWN MEDICATION TO TREAT. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED BRONCHIAL PERITIS THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE BRONCHIAL PERITIS. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S BRONCHIAL PERITIS WAS NOT REPORTED. IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM BRONCHIAL PERITIS. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Bronchitis

  MAUDE report 9105501 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF BRONCHIAL PERITIS REQUIRING UNKNOWN MEDICATION TO TREAT. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED BRONCHIAL PERITIS THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE BRONCHIAL PERITIS. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S BRONCHIAL PERITIS WAS NOT REPORTED. IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM BRONCHIAL PERITIS. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Bronchitis

  MAUDE report 9105361 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA REQUIRING UNKNOWN MEDICATION TO TREAT AND PROLONGED/EXTENDED HOSPITALIZATION. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED ASTHMA THAT WAS TREATED WITH SYSTEMIC STEROIDS. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM ASTHMA. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2018 THE PATIENT DEVELOPED ASTHMA THAT WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE ASTHMA. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED TO TREAT THE ASTHMA WAS NOT REPORTED. IT WAS NOT NECESSARY TO HOSPITALIZE THE PATIENT

  Patient problems: Asthma

  MAUDE report 9105086 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED LOWER RESPIRATORY TRACT INFECTION AND WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE LOWER RESPIRATORY TRACT INFECTION. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED WAS NOT REPORTED. IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM LOWER RESPIRATORY TRACT INFECTION. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 9105025 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO MEDICAL TREATMENT WAS GIVEN TO THE PATIENT AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2018 THE PATIENT DEVELOPED ASTHMA AND WAS PRESENTED TO THE EMERGENCY ROOM (ER). THE PATIENT WAS TREATED WITH SYSTEMIC STEROIDS AND IT WAS NOT NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED

  Patient problems: Asthma; No Code Available

  MAUDE report 9105011 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2018 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2018 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2018 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO TREATMENT WAS PERFORMED AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2018 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS. ON (B)(6) 2018 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 9104966 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED BACTERIAL PNEUMONIA AND WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE BACTERIAL PNEUMONIA. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED WAS NOT REPORTED. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM BACTERIAL PNEUMONIA. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2017 THE PATIENT DEVELOPED BRONCHITIS AND WAS ADMINISTERED OR INCREASED WITH A DRUG TO TREAT THE BRONCHITIS. THE EXACT TYPE OF MEDICATION ADMINISTERED OR INCREASED WAS NOT REPORTED. IT WAS NECESSARY HOSPITALIZE THE PATIENT DUE TO THIS EVENT. ON

  Patient problems: Asthma; Bronchitis; No Code Available; Pneumonia; Unspecified Infection

  MAUDE report 9098966 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO TREATMENT WAS PERFORMED AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS.

  Patient problems: No Code Available

  MAUDE report 9078690 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF PERIBRONCHIOLITIS TYPICALLY CAUSED BY A VIRAL INFECTION. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED PERIBRONCHIOLITIS. NO TREATMENT WAS PERFORMED AND IT WAS NOT NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOLLOWING THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM PERIBRONCHIOLITIS.

  Patient problems: No Code Available

  MAUDE report 9078500 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA EXACERBATION REQUIRING HOSPITALIZATION AND UNKNOWN MEDICATION TO TREAT. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE THIRD BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT/LEFT UPPER LOBE OF THE LUNGS. NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED ASTHMA AND WAS PRESENTED TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH STEROIDS AND AN ADDITIONAL MEDICATION. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S ASTHMA WAS NOT REPORTED. IT WAS NECESSARY TO HOSPITALIZE THE PATIENT DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM THE ASTHMA EXACERBATION. THE DATE OF THE PATIENT'S DISCHARGE FROM THE HOSPITAL WAS NOT REPORTED.

  Patient problems: Asthma

  MAUDE report 8957973 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA REQUIRING PROLONGED/EXTENDED HOSPITALIZATION. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED ASTHMA THAT WAS TREATED WITH STEROIDS. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM ASTHMA. ON (B)(6) 2017 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Asthma

  MAUDE report 8946496 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE FIRST BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE RIGHT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED ASTHMA THAT WAS TREATED WITH STEROIDS AND AN ADDITIONAL MEDICATION. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S ASTHMA WAS NOT REPORTED. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM ASTHMA. ON (B)(6) 2017 THE PATIENT DEVELOPED BACTERIAL PNEUMONIA THAT WAS TREATED WITH AN UNKNOWN ADDITIONAL MEDICATION. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S BACTERIAL PNEUMONIA WAS NOT REPORTED. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIE

  Patient problems: Asthma; Pneumonia

  MAUDE report 8946145 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY (BT) CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF ASTHMA REQUIRING EXTENDED/PROLONGED HOSPITALIZATION AND UNKNOWN MEDICATION TO TREAT. ON (B)(6) 2017 THE PATIENT WAS ADMITTED TO THE HOSPITAL AS PLANNED BY THE PHYSICIAN FOR THE BRONCHIAL THERMOPLASTY TREATMENT. ON (B)(6) 2017 THE PATIENT UNDERWENT THE SECOND BRONCHIAL THERMOPLASTY PROCEDURE PERFORMED IN THE LEFT LOWER LOBE OF THE LUNGS. NO ISSUES NOTED WITH THE DEVICE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT DEVELOPED ASTHMA THAT WAS TREATED WITH STEROIDS AND AN ADDITIONAL MEDICATION. THE EXACT TYPE OF DRUG THAT WAS ADMINISTERED OR INCREASED TO TREAT THE PATIENT'S ASTHMA WAS NOT REPORTED. IT WAS NECESSARY TO EXTEND THE PATIENT'S HOSPITALIZATION DUE TO THIS EVENT. ON (B)(6) 2017 THE PATIENT RECOVERED FROM ASTHMA AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Asthma

  MAUDE report 8946040 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080032. One submission often covers many models, so check the product and lot details in each record.

• Z-1748-2013 · May 28, 2013 · Terminated
  Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scie