Portex 101/870/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517077988), received between Dec 12, 2023 and Apr 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Crack

  IT WAS REPORTED THAT THERE WAS A CRACKED SUCTIONAID PORT. THE CARE GIVER MANAGED TRACHEOSTOMY CARE AT HOME, ATTENDED CLINIC FOR TRACHEOSTOMY CHANGE. THE ITEM WAS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889778 ↗
• InjuryMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EMERGENCY TRACH CHANGE WAS PERFORMED DUE TO A CUFF ISSUE. THE CUFF POPPED OFF WITHOUT MUCH PRESSURE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717484 ↗
• MalfunctionDec 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS INSERTED ON THE (B)(6) 2023. WITHIN 10 DAYS THE WRITING HAS RUBBED OFF ON THE PILOT BALLOON. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352797 ↗
• MalfunctionDec 18, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS INSERTED ON THE (B)(6) 2023. WITHIN 10 DAYS THE WRITING HAS RUBBED OFF ON THE PILOT BALLOON. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352446 ↗
• MalfunctionDec 12, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT USE THERE WAS AIR LEAKAGE FROM THE CUFF AND ITS USE WAS DISCONTINUED. THE EVENT OCCURRED LATE (B)(6) 2023. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314415 ↗