Portex 100/899/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315060465), received between Nov 10, 2025 and Jan 15, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH TRACHEOSTOMY TUBE WHERE CLIP DOESN¿T HOLD AND TUBE MIGRATES. TO RESOLVE THE ISSUE A NEW TRACHEOSTOMY TUBE WAS INSERTED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078862 ↗
• MalfunctionJan 13, 2026Disconnection

  IT WAS REPORTED THAT DURING THE TRACHEOSTOMY EXCHANGE, THE TUBE CAME OUT. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058943 ↗
• MalfunctionNov 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT HAD A TRACHEOSTOMY EXCHANGE ON (B)(6) 2025 WITH THE SAME TUBE TYPE, DIFFERENT LOT NUMBER. ON THE MORNING OF THE EVENT AT 9:30, THEY WERE NOTIFIED THAT THE TUBE HAD COME OUT. ON APPROACHING THE BED SPACE THE ANESTHETISTS TOLD THEM THAT WHEN HE ARRIVED THE CLIP WAS UNDONE. THEY TOOK OVER PATIENTS AIRWAY AND REINSERTED ANOTHER TUBE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513817 ↗