Portex 101/815/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15019517077360), received between Jun 23, 2021 and Dec 18, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT'S TRACHEOSTOMY TUBE PILOT LINE WAS FOUND TO BE DISCONNECTED FROM PILOT BALLOON. WHEN REINSERTED INTO BALLOON, WAS NOTED TO STILL HOLD PRESSURE BUT DECISION MADE TO CHANGE TRACH TUBE FOR SAFETY PURPOSES. THE TRACH TUBE WAS DEFECTIVE. PILOT LINE SHOULD NOT DISCONNECT FROM BALLOON; APPEARS IT WAS NOT GLUED PROPERLY BY MANUFACTURER. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839419 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Leak/Splash; Material Rupture; Fluid/Blood Leak; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE CUFF LEAKED AFTER PLACEMENT. ONE REPORT SHOWED HIGH CUFF PRESSURE. THE TRACHEOSTOMY CUFF BALLOON BURST, SO AN EMERGENCY EXCHANGE WAS DONE USING A DISTAL XLT #6 SHILEY AFTER THE PROCEDURE. THE EVENT HAPPENED IN THE HOSPITAL AND WAS HANDLED BY A HEALTHCARE PROFESSIONAL. MEDICAL INTERVENTION WAS NEEDED, INCLUDING A TRACH EXCHANGE AND A FOLLOW-UP CHEST X-RAY. THERE WAS NO DEATH OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341355 ↗
• MalfunctionAug 22, 2024Material Puncture/Hole; Air/Gas in Device; Material Puncture/Hole; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS SOME AIR IN PILOT BALLOON. WITHDREW 4 CC OF AIR USING 10 CC SYRINGE. TRACH WAS REMOVED WITH NO INCIDENT TO PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030587 ↗
• MalfunctionOct 4, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE PHYSICIAN THAT THE BALLOON REINFLATED (SPONTANEOUSLY) DURING REMOVAL. THE DEVICE WAS EASILY DEFLATED AND FULLY REMOVED. NO PATIENT INJURY, NO NEGATIVE OR LASTING OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871297 ↗
• MalfunctionJul 12, 2023Decrease in Pressure; Material Rupture; Decrease in Pressure; Material Rupture

  IT WAS REPORTED THAT THE TRACH RUPTURED. THIS CAUSED THE DISTAL TUBE TO LOSE PRESSURE. TUBING WAS REPLACED. NO PATIENT HARM, INJURY, OR ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312503 ↗
• MalfunctionSep 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LOT NUMBER ON FLANGE WAS NOT MATCHING THE LOT NUMBER ON THE BOX. ISSUE WAS DETECTED PRIOR TO USE WITH THE PATIENT. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410081 ↗
• InjuryFeb 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THEY INSTALLED IN THE OPERATING ROOM A FIRST BLU SELECT TRACHEOSTOMY TUBE AND INFLATED THE CUFF. WITHIN 24 HOURS THEY HAD INSTALLED 2 OF THESE TUBES (ONE ON JULY 16 AND ANOTHER ON JULY 17). BOTH WERE LEAKING AND THEY COULD NOT KEEP THE PRESSURE AND HAVE A PERFECT SEAL INTO THE PATIENT'S TRACHEA. THEY HAD TO INSTALL A THIRD TUBE (AN OLD PORTEX DIC TUBE) TO BE ABLE TO KEEP A GOOD SEAL AND WITHOUT HAVING TO RE-INFLATE THE CUFF CONTINUOUSLY. ALL THESE PROCEDURES IN THE FIRST 24 HOURS, NEEDED A LOT FROM ALL THE CLINICAL STAFF AND THEY HAD TO ADMINISTERED BENZODIAZEPIN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472143 ↗
• InjuryFeb 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THEY INSTALLED IN THE OPERATING ROOM A FIRST BLU SELECT TRACHEOSTOMY TUBE AND INFLATED THE CUFF. WITHIN 24 HOURS THEY HAD INSTALLED 2 OF THESE TUBES (ONE ON JULY 16 AND ANOTHER ON JULY 17). BOTH WERE LEAKING AND THEY COULD NOT KEEP THE PRESSURE AND HAVE A PERFECT SEAL INTO THE PATIENT'S TRACHEA. THEY HAD TO INSTALL A THIRD TUBE (AN OLD PORTEX DIC TUBE) TO BE ABLE TO KEEP A GOOD SEAL AND WITHOUT HAVING TO RE-INFLATE THE CUFF CONTINUOUSLY. ALL THESE PROCEDURES IN THE FIRST 24 HOURS, NEEDED A LOT FROM ALL THE CLINICAL STAFF AND THEY HAD TO ADMINISTERED BENZODIAZEPIN TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471758 ↗
• MalfunctionJun 25, 2021Difficult to Remove; Difficult to Remove

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT WAS FOUND TO BE DEVIATED DOWNWARD AND DIFFICULT TO REMOVE THE INNER CANNULA. THIS WAS OBSERVED WITH MANY TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068181 ↗
• MalfunctionJun 23, 2021Difficult to Remove; Difficult to Remove

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT WAS FOUND TO BE DEVIATED DOWNWARD AND DIFFICULT TO REMOVE THE INNER CANNULA. THIS WAS OBSERVED WITH MANY TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054483 ↗
• MalfunctionJun 23, 2021Difficult to Remove; Difficult to Remove

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT WAS DEVIATED AND DIFFICULT TO REMOVE INNER CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051222 ↗
• InjuryJun 23, 2021Difficult to Remove; Difficult to Remove

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT WAS IN STUDY AND WAS FOUND TO BE DEVIATED INTO THE CHEST WALL, MAKING IT DIFFICULT TO REMOVE THE INNER CANNULA, THIS IN TURN CAUSED CHEST PRESSURE TO THE PATIENT .

  Patient problems: Chest Pain

  MAUDE report 12051031 ↗