Portex 101/860/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019517077933), received between Feb 1, 2022 and Sep 21, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Gas/Air Leak

  It was reported that an air leak was observed from the cuff while the device was in use during an infusion at the healthcare facility. The event involved the patient; however, no patient harm or adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839679 ↗
• MalfunctionAug 7, 2026Gas/Air Leak

  It was reported that the BLUESELECT 8.0 SUCTIONAID Cuffed tracheostomy tube experienced five instances of cracking in the blue plastic component of the subglottic suction port over a four-week period. The issue was observed in size 8 and size 9 Portex tracheostomy tubes. The cracks compromised the ability to maintain adequate back pressure, resulting in ineffective subglottic suctioning. There were patient involvement and no harm or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180292 ↗
• MalfunctionJan 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PILOT BALLOON SECTION WAS CUT OFF HALFWAY THROUGH. THE EVENT OCCURRED DURING PATIENT USE, IN LATE (B)(6). NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586799 ↗
• MalfunctionJan 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A CUFF LEAK CHECK PRIOR TO PATIENT USE, THE CUFF DID NOT INFLATE. WHEN THE EVENT WAS OBSERVED ITS USE WAS DISCONTINUED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556969 ↗
• MalfunctionJan 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK THE CUFF DID NOT INFLATE. THE CUFF ONLY SWELLED SLIGHTLY WHEN CHECKING THE CUFF. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556892 ↗
• MalfunctionDec 22, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT 4 DAYS AFTER INSERTING THE CANNULA, A CUFF AIR LEAK WAS OBSERVED. AFTER THAT, THE CANNULA WAS REPLACED. SINCE THERE WAS NO PROBLEM WITH THE CUFF CHECK BEFORE INTUBATION, IT IS POSSIBLE THAT THE CUFF WAS SCRATCHED DURING OR AFTER INTUBATION. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384547 ↗
• MalfunctionSep 13, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE OUTER BOX LABEL INDICATED PRODUCT WAS 100/860/080 HOWEVER, THE INNER PACKAGE CONTAINS PRODUCT 100/860/070. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410054 ↗
• InjuryFeb 1, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE USE THE PRODUCT ON (B)(6) AND CHECKED THE CUFF PRESSURE USING A MANUAL CUFF PRESSURE GAUGE. ON (B)(6), A NURSE NOTICED THE BACKFLOW PREVENTION VALVE WAS MISSING. ALSO, THE CUFF PRESSURE WAS GRADUALLY GOING DOWN. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418960 ↗