Mallinckrodt 8888247064Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521133136), received between Jun 27, 2025 and Aug 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

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.

• MalfunctionAug 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS NOT HOLDING AIR SHORTLY AFTER BEING PLACED. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 22790593 ↗
• InjuryJun 27, 2025Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  IT WAS REPORTED THAT A CUFFED TRACHEOSTOMY TUBE WAS THEN INSERTED INTO THE TRACHEA, THE BALLOON WAS INFLATED, AND THE CIRCUIT WAS CONNECTED. THERE WAS POSITIVE END-TIDAL CO2. IT WAS NOTED SHORTLY THEREAFTER THAT THE PATIENT WAS NOT ACHIEVING ADEQUATE TIDAL VOLUMES ON THE VENT AND BEGAN DESATURATING TO LOW 80'S. THE PATIENT WAS BRANCHED PROMPTLY VIA THE TRACHEOSTOMY AND IT WAS NOTED THAT THE INFLATED CUFF WAS EXTENDING DISTAL TO THE END OF THE TUBE, PRODUCING SEVERE STENOSIS OF THE OPENING OF THE TRACHEOSTOMY TUBE. THE BALLOON WAS PARTIALLY DEFLATED AND THE OCCLUSION PROBLEM WAS RESOLVED AS SEEN ON BRONCHOSCOPY. AT THIS TIME, THE PATIENTS END TITLE, TIDAL VOLUMES, AND SATURATION ALL NORMALIZED.

  Patient problems: Hypoventilation; Low Oxygen Saturation; Stenosis

  MAUDE report 22350049 ↗