Portex 100/897/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019315107191), received between May 25, 2016 and May 26, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY CUFF WAS LEAKING AS SOON AS IT WAS INSERTED INTO THE PATIENT. PER REPORTER, THERE WERE 4 SEPARATE REGISTERED INCIDENCES. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279095 ↗
• MalfunctionMay 26, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY CUFF WAS LEAKING AS SOON AS IT WAS INSERTED INTO THE PATIENT. PER REPORTER, THERE WERE 4 SEPARATE REGISTERED INCIDENCES. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279093 ↗
• MalfunctionMay 26, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY CUFF WAS LEAKING AS SOON AS IT WAS INSERTED INTO THE PATIENT. PER REPORTER, THERE WERE 4 SEPARATE REGISTERED INCIDENCES. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279086 ↗
• MalfunctionMay 24, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY CUFF WAS LEAKING AS SOON AS IT WAS INSERTED INTO THE PATIENT. PER REPORTER, THERE WERE 4 SEPARATE REGISTERED INCIDENCES. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25266869 ↗
• MalfunctionJul 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PACKAGE INCLUDED OBTURATOR FOR SIZE 9.0 INSTEAD OF SIZE 7, AND THEREFORE THE OBTURATOR DID NOT FIT INSIDE THE CANNULA. AS THE PROCEDURE WAS PERFORMED IN THE OPERATING ROOM, THE CANNULA COULD BE PLACED IN THE PATIENT WITH THE HELP OF OTHER INSTRUMENTS. THE EVENT OCCURRED IN THE HOSPITAL AND THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554172 ↗
• MalfunctionNov 18, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT "CUFF DID NOT KEEP THE PRESSURE. CUFF WAS TESTED BEFORE USE." "WHEN THE SYRINGE WAS TAKEN OUT OF THE PILOT CUFF AFTER THE CUFF WAS FILLED THE AIR DID NOT STAY. WHEN FIRST CHECKED, THE SYRINGE WAS CONNECTED TO THE PILOT CUFF. AND AFTER INTUBATION THE CUFF WAS FILLED AND THE SYRINGE WAS REMOVED, THE CUFF WAS DEFLATED." NO ADDITIONAL INFORMATION WAS AVAILABLE FOR THIS EVENT. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20713552 ↗
• MalfunctionMay 19, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PRODUCT IS NOT SEALED AND STERILE UPON OPENING. ON ONE, THE JOINT TO THE WHITE PAPER ON THE INNER PACKAGING WAS LOOSE, AND OPEN TO THE PRODUCTS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437536 ↗
• MalfunctionMar 17, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A TRACHEOSTOMY PROCEDURE PREPARATION, THE USER COULD NOT FULLY CLAMP THE GUIDEWIRE AND WAS NOT ABLE TO CLOSE THE ADJUSTABLE FLANGE ISSUE WAS OBSERVED DURING DEVICE CHECK AND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802978 ↗
• InjuryJul 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A TRACHEOSTOMY PROCEDURE AFTER PLACING A PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE, THE CUFF GETS EMPTY. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7712544 ↗
• InjuryMay 25, 2016Bent; Occlusion Within Device; Bent; Occlusion Within Device

  DISTRIBUTOR REPORTED ON BEHALF OF USER FACILITY THAT THE DEVICE WAS IN USE WITH PATIENT WHO WAS LOCATED IN AN INTENSIVE CARE UNIT FOR BURN PATIENTS (TIME IN USE NOT PROVIDED). THE REPORTER STATED THE PATIENT WAS MANUALLY VENTILATED THROUGH THE TUBE. THE REPORTER STATED THE PATIENT SHOWED DECREASE IN OXYGEN SATURATION LEVELS AND IN RESPONSE THE PATIENT WAS SUCTIONED. THE TREATING PHYSICIAN ADMINISTERED ADDITIONAL OXYNORM, FENTANYL AND PROPOFOL TO PATIENT; AFTER THIS THE PATIENT VENTILATION BECAME EASIER WITH OXYGEN SATURATION MEASURED AT 94%. ACCORDING TO REPORTER, THE PATIENT SATURATION DECREASED AGAIN AND TREATING STAFF SUSPECTED PATIENT HAD DEVELOPED EMPHYSEMA: IN RESPONSE THE PATIENT WAS EXAMINED VIA BRONCHOSCOPY. THE EXAMINATION SHOWED THE TRACHEOSTOMY TUBE WAS OBSTRUCTED AND THE SCOPE COULD NOT BE PASSED THROUGH IT. THE TUBE WAS REMOVED AND PATIENT WAS RE-INTUBATED: REPORTER STATED THAT THE REPLACEMENT TUBE COULD NOT BE ADVANCED PAST THE VOCAL CORDS DUE TO RESISTANCE. ACCORDING TO REPORTER, EXAMINATION AFTER THE RE-INTUBATION SHOWED SUBCUTANEOUS EMPHYSEMA AND PNEUMOTHORAX ON BOTH SIDES. REPORTER DID NOT CONFIRM WHETHER EMPHYSEMA AND PNEUMOTHORAX WAS PRESENT PRIOR TO INTUBATION

  Patient problems: Pneumothorax; Pulmonary Emphysema; Respiratory Distress

  MAUDE report 5678480 ↗