Portex 101/860/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 15019517076158), received between Aug 26, 2020 and Aug 6, 2026 — classified as 18 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (45 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 25 most recent of 188 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161877 ↗
• MalfunctionJul 8, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748486 ↗
• MalfunctionJun 16, 2026Crack

  IT WAS REPORTED THAT CRACKED SUBGLOTTIC SUCTION PORT WAS NOTED BY NURSING STAFF WHEN ATTEMPTING TO ASPIRATE. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521881 ↗
• MalfunctionMar 23, 2026Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT DURING PATIENT USE THE TRACHEOSTOMY TUBE HAD AN AIR LEAK. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM / ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662420 ↗
• MalfunctionMar 16, 2026Gas/Air Leak

  IT WAS REPORTED THAT STAFF HAD TO INFLATE THE CUFF EVERY HOUR. DUE TO ISSUES WITH TRACH TUBE THEY WERE ADVISED AN URGENT TRACH CHANGE. THE PROBLEM WAS FIXED BY REPLACING THE TRACH TUBE. THE INCIDENT TOOK PLACE AT PATIENT HOME. THE DEVICE WAS MANIPULATED BY A HEALTHCARE PROFESSIONAL, THERE WAS PATIENT INVOLVEMENT, THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607582 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  IT WAS STATED SUSPICION OF CUFF LEAKED. THE EVENT OCCURRED DURING USE AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518743 ↗
• MalfunctionFeb 17, 2026Inflation Problem

  IT HAS BEEN REPORTED THAT THE CUFF DOES NOT INFLATE DUE TO DEFORMATION OR KINKING OF THE PILOT BALLOON TUBE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370465 ↗
• MalfunctionJan 14, 2026Device Damaged Prior to Use

  IT WAS REPORTED THAT NOTHING CAME FROM THE SUBGLOTTIC AREA EVEN THOUGH THE HARD PLASTIC PART WHERE THE SYRINGE IS ATTACHED IS INTACT. WHEN INVESTIGATING THE ISSUE, IT WAS TRIED TO BEND THE TUBE TOWARDS THE PATIENT AND WHEN PULLING ON THE SYRINGE, IT DID NOT CREATE A VACUUM AS EXPECTED BUT INSTEAD DREW IN AIR, WHICH MEANS IT MUST BE DAMAGED SOMEWHERE BETWEEN THE HARD PLASTIC AND THE TUBING ITSELF, IN THE SEAM. THE DEFECT IS NOT VISIBLE BECAUSE THE HARD PLASTIC HAS A KIND OF SKIRT, AND THEY DID NOT WANT TO BREAK IT FURTHER TO EXAMINE IT. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067567 ↗
• MalfunctionDec 31, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR WAS LEAKING FROM THE CUFF. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937279 ↗
• MalfunctionDec 29, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CUFF LEAK WAS IDENTIFIED DURING PATIENT USE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906912 ↗
• MalfunctionNov 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AFTER PERFORMING A SURGICAL TRACHEOSTOMY, THE CUFF PRESSURE TENDED TO DROP EASILY, AND THE ALARM OF THE AUTOMATIC CUFF PRESSURE MONITOR WENT OFF SEVERAL TIMES. AFTER A CHANGE IN POSITION, THERE WAS ALSO VOICE LEAKAGE, SO THE TUBE WAS REPLACED WITH A NEW ONE TWO AND A HALF HOURS AFTER PLACEMENT. AFTER REMOVAL, WHEN THE TRACHEOSTOMY TUBE WAS IMMERSED IN WATER FOR INSPECTION, AIR LEAKAGE WAS OBSERVED FROM THE UPPER PART OF THE CUFF. THIS OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453612 ↗
• MalfunctionOct 30, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED CUFF DEFLATION. THIS OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429877 ↗
• InjuryJun 25, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUFF DEFLATED AFTER THE TRACHEOSTOMY TUBE WAS INSERTED. IT ALSO DEFLATED DURING SUCTIONING, SO THE REPORTER TRIED TO REPLACE THE TUBE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327597 ↗
• MalfunctionJun 24, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT AIR ESCAPES FROM THE CUFF. THE EVENT OCCURRED DURING PATIENT USE, AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321035 ↗
• MalfunctionJun 6, 2025Deflation Problem; Disconnection; Deflation Problem; Disconnection

  IT WAS REPORTED THAT A CIRCUIT DISCONNECTION ALARM HAD SOUNDED AND WHEN THE PRODUCT WAS CHECKED IT WAS FOUND THAT THE CANNULA HAD COME OUT. THE BAND WAS STILL ATTACHED. THE CUFF PRESSURE WAS SLIGHTLY DECREASED AND WAS DEFLATED. THE CANNULA HAD BEEN REPLACED THE DAY BEFORE. THE DOCTOR TRIED TO REINSERT THE SAME CANNULA; THE CURRENT CANNULA INFLATED WHEN THE CUFF PRESSURE WAS APPLIED BUT COULD NOT BE DECOMPRESSED. THE CANNULA WAS REPLACED WITH A NEW ONE. THE EVENT OCCURRED DURING PATIENT USE THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160243 ↗
• MalfunctionJun 6, 2025Disconnection; Gas/Air Leak; Disconnection; Gas/Air Leak

  IT WAS REPORTED THAT VALVE LEAKS IN THE CUFF TUBE. LEAKAGE OCCURRED WHEN THE CUFF PRESSURE GAUGE WAS DISCONNECTED, THOUGH CUFFS THEMSELVES SEEMED FINE. SEVERAL PATIENTS NEEDED FREQUENT TUBE CHANGES FOR THIS REASON. RETAINED CANNULAS SHOWED NO LEAKAGE OVERNIGHT. A 5¿10 CM H2O PRESSURE DROP WHEN CONNECTED TO THE GAUGE IS A KNOWN ISSUE. SOME WARD STAFF KEPT THE GAUGE CONNECTED CONTINUOUSLY. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158335 ↗
• MalfunctionJun 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT MULTIPLE ISSUES OCCURRED IN TRACHEOSTOMY TUBES. IN ONE CASE, THE PATIENT HAD TO TAPE THE PORT TO PREVENT LEAKING. THE FAULT WAS DISCOVERED AT THE PATIENT'S HOME BY THEIR CAREER AFTER INSERTION AND USE. PROPER ASPIRATION TECHNIQUE USING A 10ML SYRINGE WAS CONFIRMED. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING A TRACHEOSTOMY TUBE CHANGE. IN ANOTHER INSTANCE, THE CAREER TAPED OVER THE CRACK. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158254 ↗
• MalfunctionJun 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT MULTIPLE ISSUES OCCURRED WITH THE SIZE 8 SUCTION AID PORT CRACKING ON TRACHEOSTOMY TUBES. IN ONE CASE, THE PATIENT HAD TO TAPE THE PORT TO PREVENT LEAKAGE. THE FAULT WAS DISCOVERED AT THE PATIENT'S HOME BY THEIR CAREER AFTER INSERTION AND USE. PROPER ASPIRATION TECHNIQUE USING A 10ML SYRINGE WAS CONFIRMED. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING A TRACHEOSTOMY TUBE CHANGE. IN ANOTHER INSTANCE, THE CAREER TAPED OVER THE CRACK. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158209 ↗
• MalfunctionJun 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT MULTIPLE ISSUES OCCURRED IN TRACHEOSTOMY TUBES. IN ONE CASE, THE PATIENT HAD TO TAPE THE PORT TO PREVENT LEAKING. THE FAULT WAS DISCOVERED AT THE PATIENT'S HOME BY THEIR CAREER AFTER INSERTION AND USE. PROPER ASPIRATION TECHNIQUE USING A 10¿ML SYRINGE WAS CONFIRMED. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING A TRACHEOSTOMY TUBE CHANGE. IN ANOTHER INSTANCE, THE CAREER TAPED OVER THE CRACK. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137107 ↗
• InjuryMay 20, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUFF DEFLATED AFTER THE TRACHEOSTOMY TUBE WAS INSERTED. IT ALSO DEFLATED DURING SUCTIONING, SO THE REPORTER TRIED TO REPLACE THE TUBE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049469 ↗
• MalfunctionMay 1, 2025Moisture or Humidity Problem; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE IN THE DEVICE THE WATER ACCUMULATES IN THE PILOT BALLOON (CUFF). THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943733 ↗
• MalfunctionApr 3, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE CUFF PRESSURE COULD NOT BE MAINTAINED AT A CONSTANT LEVEL FOR SOME TIME, BUT THIS IMPROVED AFTER A WHILE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761162 ↗
• MalfunctionMar 3, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COULD NOT INFLATE. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510630 ↗
• MalfunctionJan 15, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT WATER ACCUMULATES IN THE CUFF. ALTHOUGH THERE IS A DESCRIPTION IN THE PACKAGE INSERT, WE FELT THAT THERE WERE MORE THAN EXPECTED. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159796 ↗
• MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE CUFF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140114 ↗