AERO® G (REF 90129-212)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450703960), received between Sep 11, 2024 and Sep 12, 2024 — classified as 2 deaths.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 12, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  THE ACCOUNT ALLEGES THAT DURING A TRACHEOBRONCHIAL STENT DEPLOYMENT PROCEDURE, THE CLINICIAN WAS UNABLE TO DEPLOY A STENT BY SQUEEZING THE DEPLOYMENT TRIGGER. THEY SWITCHED TO A NEW STENT AND HAD A SIMILAR ISSUE BUT WERE SUCCESSFUL IN DEPLOYING THE STENT, BUT THE STENT HAD ENFOLDED [INVAGINATED]. THE 12X40 STENT WAS PLACED VIA DIRECT VISION. NO DAMAGE WAS NOTED TO THE STENT OR THE DEVICE BEFORE OR DURING THE DEPLOYMENT ATTEMPT. THE CLINICIAN TRIED TO ADJUST THE STENT USING A BALLOON INFLATION TECHNIQUE AND ENDED UP PERFORATING THE TRACHEOBRONCHIAL WALL. THE PHYSICIAN STATES THE PATIENT WAS NOT IN GOOD CONDITION BEFORE THE PROCEDURE. THE 58-YEAR-OLD FEMALE PATIENT WHO SUFFERED FROM A LARGE CANCEROUS ENDOBRONCHIAL TUMOR LIKELY CONTRIBUTED TO THE PATIENT'S TRACHEOBRONCHIAL PERFORATION BY WEAKENING THE TRACHEAL WALL DURING THE BALLOON EXPANSION TECHNIQUE RESULTED IN PERFORATION. A CODE WAS INITIATED PER HOSPITAL PROTOCOLS BUT WAS UNSUCCESSFUL. THE PATIENT EXPIRED AT 4:15 PM THE SAME DAY. COD MASSIVE HEMORRHAGE. THE PATIENT ALSO EXPERIENCED HEMOPTYSIS 1 WEEK BEFORE THE ACTUAL STENT PLACEMENT AND UNDERWENT PHOTODYNAMIC THERAPY (PDT) TREATMENT 4 WEEKS BEFORE THAT ACTUAL STENT PLACEMENT. A

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20204675 ↗
• DeathSep 11, 2024Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  THE ACCOUNT ALLEGES THAT DURING A TRACHEOBRONCHIAL STENT DEPLOYMENT PROCEDURE, THE CLINICIAN WAS UNABLE TO DEPLOY A STENT BY SQUEEZING THE DEPLOYMENT TRIGGER. THEY SWITCHED TO A NEW STENT AND HAD A SIMILAR ISSUE BUT WERE SUCCESSFUL IN DEPLOYING THE STENT, BUT THE STENT HAD ENFOLDED [INVAGINATED]. THE 12X40 STENT WAS PLACED VIA DIRECT VISION. NO DAMAGE WAS NOTED TO THE STENT OR THE DEVICE BEFORE OR DURING THE DEPLOYMENT ATTEMPT. THE CLINICIAN TRIED TO ADJUST THE STENT USING A BALLOON INFLATION TECHNIQUE AND ENDED UP PERFORATING THE TRACHEOBRONCHIAL WALL. THE PHYSICIAN STATES THE PATIENT WAS NOT IN GOOD CONDITION BEFORE THE PROCEDURE. THE 58-YEAR-OLD FEMALE PATIENT WHO SUFFERED FROM A LARGE CANCEROUS ENDOBRONCHIAL TUMOR LIKELY CONTRIBUTED TO THE PATIENT'S TRACHEOBRONCHIAL PERFORATION BY WEAKENING THE TRACHEAL WALL DURING THE BALLOON EXPANSION TECHNIQUE RESULTED IN PERFORATION. A CODE WAS INITIATED PER HOSPITAL PROTOCOLS BUT WAS UNSUCCESSFUL. THE PATIENT EXPIRED AT 4:15 PM THE SAME DAY. COD MASSIVE HEMORRHAGE. THE PATIENT ALSO EXPERIENCED HEMOPTYSIS 1 WEEK BEFORE THE ACTUAL STENT PLACEMENT AND UNDERWENT PHOTODYNAMIC THERAPY (PDT) TREATMENT 4 WEEKS BEFORE THAT ACTUAL STENT PLACEMENT. A

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20194492 ↗