Alair Bronchial Thermoplasty RF Controller ATS 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729796695), received between Aug 17, 2022 and Oct 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BT CONTROLLER WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, THERE WAS NO OUTPUT IN THE UNIT, AND IT WAS NOT WORKING. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15619268 ↗
• MalfunctionAug 17, 2022Device Alarm System; Material Integrity Problem; Device Alarm System; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-04602 AND 3005099803-2022-04603 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 15243069 ↗

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