Portex 101/870/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 15019517076226), received between Nov 21, 2020 and Sep 9, 2026 — classified as 6 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (17 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680900 ↗
• MalfunctionSep 9, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680896 ↗
• MalfunctionAug 7, 2026Gas/Air Leak

  It was reported that the BLU Select Suction aid tube experienced cuff leakage during use. This issue had the potential to result in inadequate ventilation. There was patient involvement; however, no injury, harm, or adverse health consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50182078 ↗
• MalfunctionJul 1, 2026Crack

  IT WAS REPORTED THAT THE PORTEX TUBE HAD CRACKED SUBGLOTTIC PORTS IN MULTIPLE TRACHEOSTOMY DEVICES, AND IT WAS IDENTIFIED AFTER TRACHEOSTOMY INSERTION. THE PORT REMAINED FUNCTIONAL WHEN PRESSURE WAS APPLIED TO THE NOZZLE WITH THE THUMB AND FOREFINGER DURING SUCTIONING OF THE SUBGLOTTIC PORT. THE EVENT OCCURRED IN THE DEVICE WAS IN USE WITH THE PATIENT. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681499 ↗
• MalfunctionMay 21, 2026Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE BLUSELECT 8.0, SUCTIONAID, CUFFED, NON-FEN HAD A HOLE IN THE SUCTION LINE DURING PATIENT USE WHICH WILL CAUSE LEAKING OF AIR OR INHALED MEDICATION DURING USE THAT COULD LEAD TO INADEQUATE DELIVERY OF THERAPY OR INTRODUCTION OF CONTAMINANTS INTO THE SYSTEMS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241567 ↗
• MalfunctionFeb 5, 2026Gas/Air Leak; Air/Gas in Device

  IT WAS REPORTED THAT AFTER THE REPLACEMENT AT THE PATIENT'S HOME, A LEAK WAS CONFIRMED THE NEXT DAY. THIS OCCURRED DURING USE. THERE WAS UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268906 ↗
• MalfunctionJan 12, 2026Leak/Splash

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046615 ↗
• MalfunctionDec 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WATER HAD LEAKED OUT OF THE 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 23774133 ↗
• MalfunctionDec 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760869 ↗
• MalfunctionSep 18, 2025Crack; Crack

  IT WAS REPORTED THAT THE SUCTION PORT OBSERVED TO BE CRACKED THE DAY AFTER IT WAS PLACED. THE ABOVE SUCTION PORT CAN STILL BE USED. A SLIP TIP SYRINGE WAS USED AT ALL TIMES. EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083350 ↗
• MalfunctionJul 17, 2025Crack; Crack

  IT WAS REPORTED THAT A PATIENT USING HOME MECHANICAL VENTILATION VIA TRACHEOSTOMY WAS USING A PORTEX BRAND TRACHEAL CANNULA WHICH PRESENTED A FRACTURE BETWEEN THE INTERNAL AND EXTERNAL DEVICE, PUTTING THE PATIENT'S VENTILATION AT RISK 3 TIMES. AS SOON AS THEY NOTICED, THEY MADE THE REPLACEMENT, THEY PERFORM REGULAR SCHEDULED DEVICE REPLACEMENTS. THERE WAS MECHANICAL VENTILATION COMPROMISE DUE TO AIR LEAK AND DIFFICULTY IN THE MACHINE MAINTAINING VOLUME. EVENT OCCURRED WHILE USE IN PATIENT. THERE WAS NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530515 ↗
• MalfunctionJul 14, 2025Tidal Volume Fluctuations; Gas/Air Leak; Tidal Volume Fluctuations; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT USING HOME MECHANICAL VENTILATION VIA TRACHEOSTOMY WAS USING A PORTEX BRAND TRACHEAL CANNULA WHICH PRESENTED A FRACTURE BETWEEN THE INTERNAL AND EXTERNAL DEVICE. THERE WAS ALMOST TOTAL FRACTURE OF THE CANNULA BODY WITH THE EXTERNAL PORTION AND LED TO LOW VOLUME VENTILATION DYSFUNCTION. THEY PERFORM REGULAR SCHEDULED DEVICE REPLACEMENTS. THERE WAS MECHANICAL VENTILATION COMPROMISE DUE TO AIR LEAK AND DIFFICULTY IN THE MACHINE MAINTAINING VOLUME. THE PATIENT'S MOTHER ALSO REPORTED THAT THE PRODUCT WAS IN USE BETWEEN 1 MONTH AND 2 MONTHS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495354 ↗
• MalfunctionMay 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CONNECTION TUBE FOR THE EXTERNAL PRESSURE CONTROLLER (INTELLICUFF) CAME LOOSE. THE REPORTER STATED THAT WHEN INSERTING THE CONNECTION TUBE INTO THE PILOT BALLOON, A PHENOMENON OCCURS WHERE IT GETS PUSHED BACK OUT. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031146 ↗
• MalfunctionApr 4, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CONNECTOR ON THE SUCTION LINE CAME OFF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775320 ↗
• MalfunctionApr 4, 2025Suction Problem; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Suction Problem; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUCTION WAS DIFFICULT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775243 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT ¿WHEN THEY TRIED TO CUFF THE NEW BLU SELECT 8.0, SUCTION AID, THE CUFF WAS BROKEN¿. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691498 ↗
• MalfunctionFeb 11, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE CONNECTOR ON THE SUCTION LINE CAME OFF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356995 ↗
• MalfunctionFeb 11, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE SUCTION WAS DIFFICULT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356927 ↗
• MalfunctionFeb 11, 2025Crack; Disconnection; Decrease in Pressure; Crack; Disconnection; Decrease in Pressure

  IT WAS REPORTED THAT THE PRODUCT HAD A "LOSS OF CUFF PRESSURE, CRACK AT BASE OF SUCTION LINE, DETACHMENT OF SUCTION CONNECTOR (BLUE)." THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356886 ↗
• InjuryDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER HAD ACCUMULATED INSIDE THE PILOT BALLOON IN A PATIENT WHO HAD BEEN USING IT CONTINUOUSLY FOR ABOUT 2 MONTHS. WHEN THE TUBE WAS REPLACED, WATER ALSO ENTERED THE CUFF. THIS 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 20833089 ↗
• MalfunctionSep 30, 2024Device Dislodged or Dislocated; Gas/Air Leak; Device Dislodged or Dislocated; Gas/Air Leak

  IT WAS REPORTED THAT POST TURN THERE WAS AUDIBLE CUFF LEAK, AND PATIENT WAS ALSO NOT VENTILATING ADEQUATELY. THE CONSULTANT ATTENDED AND EXAMINED THE PATIENT AND ADVISED THAT PATIENT NEEDS TO BE SUPINE FOR ORAL INTUBATION AS THE TRACHEOSTOMY TUBE APPEARED TO BE DISLODGED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334398 ↗
• MalfunctionSep 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE TUBE INFORMATION STICKER ATTACHED TO THEIR FILE DOES NOT INCLUDE THE LOT NUMBER AND THE EXPIRY DATE. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320953 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK ON THE VENT. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302462 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK ON THE VENT. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301743 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK ON THE VENT. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301659 ↗