AERO® 00884450030813Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450030813), received between Aug 26, 2020 and Mar 1, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMar 1, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN ESOPHOGEAL STENT REPLACEMENT DUE TO A DEVELOPED FISTULA OF AN INTRINSIC TUMOR, THE ORIGINAL STENT BROKE AS IT WAS BEING REMOVED. THE PROCEDURE WAS STOPPED AS THERE WAS A NEED TO GET CONSENT FROM THE PATIENT OR FAMILY FOR AN ESOPHOGEAL STENT AND THE PROCEDURE IS TO BE COMPLETED AT A LATER DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13636442 ↗
• InjuryAug 26, 2020Material Fragmentation; Material Separation; Migration; Material Fragmentation; Material Separation; Migration

  THE ACCOUNT ALLEGES THAT DURING A TRACHEOBRONCHIAL STENT REMOVAL PROCEDURE THE STENT FRAGMENTED WITHIN A MALE PATIENT. THE ORIGINAL STENT IMPLANT DATE WAS (B)(6) 2019. THE STENT PLACED FOR TRACHEAL STENOSIS DUE TO CANCER. NO DIFFICULTY OCCURRED DURING IMPLANTATION. THE STENT WAS SUCCESSFULLY PLACED UNDER X-RAY VISUALIZATION. NO ABNORMALITY WAS IDENTIFIED ON THE STENT POST PLACEMENT. THE STENT WAS PLACED WITHIN THE UPPER PORTION OF THE AIRWAY HOWEVER, IT MIGRATED DOWN TO THE VICINITY OF TRACHEAL BIFURCATION WITHIN A FEW DAYS AFTER THE PLACEMENT. THE STENT WAS PLACED FOR EXTRINSIC COMPRESSION. THE PHYSICIAN STATES THE STENT HAD PREVIOUSLY FRACTURED WITHIN THE PATIENT AND THE RETRIEVAL KNOT AT THE END OF THE STENT WAS PULLED, BUT ONLY A PIECE OF THE STENT WAS SUCCESSFULLY REMOVED WITHOUT RESISTANCE. THE PHYSICIAN GRASPED AS MANY OF THE STENTS SUPPORTING POINTS AS POSSIBLE WITH GRASPING FORCEPS. DURING THE REMOVAL PROCEDURE THE STENTS POLYURETHANE COVER HAD SPLIT AS WELL AND HAD OCCLUDED THE PATIENT'S TRACHEA, CAUSING A SERIOUS DECREASE IN SPO2 LEVELS. A FLEXIBLE SCOPE WAS FORCEFULLY INSERTED INTO THE PATIENT AND AIRWAY WAS CLEARED. AN INTRATRACHEAL INTUBATION TUBE WAS PLACED, AND THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457975 ↗