Portex 100/133/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 15019315020353), received between Jul 27, 2018 and Sep 8, 2026 — classified as 12 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (22 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676406 ↗
• MalfunctionJul 29, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075156 ↗
• MalfunctionMay 7, 2026Inflation Problem

  IT WAS STATED THAT THE BALLOONING DID NOT OCCUR. THE EVENT OCCURRED IMMEDIATELY ON USE AT THE HOSPITAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115858 ↗
• MalfunctionApr 20, 2026Separation Problem

  IT WAS STATED THAT THE CUFF POPPED ON THE CURRENT TUBE IN THE PATIENT'S AIRWAY. AROUND 15 MINUTES LATER THEY SAID THAT THE TUBE THEY REPLACED THE OTHER WITH, ALSO POPPED. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927823 ↗
• MalfunctionApr 20, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A SURGICAL INTUBATION PERFORMED USING FIBROSCOPY, ONCE THE INTUBATION PROBE HAD BEEN SET UP, IT WAS FOUND IMPOSSIBLE TO INFLATE THE BALLOON. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926263 ↗
• MalfunctionApr 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAKING ENDOTRACHEAL TUBE. EVENT OCCURRED IMMEDIATELY ON USE. THERE WAS PATIENT INVOLVEMENT, BUT UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874941 ↗
• MalfunctionApr 7, 2026Deflation Problem; Unintended Deflation

  IT WAS REPORTED THAT A QUALITY DEFECT WAS OBSERVED ON THE NASAL INTUBATION PROBE, THE BALLOON DEFLATES DIRECTLY AFTER BEING INFLATED. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809128 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED AFTER INTUBATION, WHEN AIR WAS INJECTED INTO THE PILOT BALLOON WITH A SYRINGE, THE RED VALVE CAP CAME OFF. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570768 ↗
• MalfunctionNov 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION, THE CUFF PRESSURE DECREASED DURING INFLATION. THE CUFF WAS SUBSEQUENTLY FULLY DEFLATED, AND A NEW INTUBATION WAS SUCCESSFULLY PERFORMED. A FUNCTIONAL CHECK WAS CONDUCTED BY INFLATING THE CUFF WHILE IT WAS IMMERSED IN WATER, WHICH RESULTED IN VISIBLE BUBBLE FORMATION, INDICATING A LEAK. ALTHOUGH THE EVENT INVOLVED A PATIENT, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511139 ↗
• MalfunctionSep 2, 2025Material Perforation; Material Perforation

  IT WAS REPORTED THAT THE TRACHEAL TUBE HAD A PERFORATED CUFF. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946285 ↗
• MalfunctionJul 15, 2025Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAKAGE CUFF POST INTUBATION NASALLY. THE PATIENT WAS EXTUBATED AND INTUBATED NASALLY WITH SECOND NASAL TUBE, HOWEVER SLOW LOSS OF CUFF PRESSURE WAS NOTED. THE PATIENT WAS SUCCESSFULLY RE-INTUBATED WITH REINFORCED NASALLY WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509320 ↗
• MalfunctionMay 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004346 ↗
• MalfunctionMar 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510859 ↗
• MalfunctionFeb 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE TUBE WAS CHECKED, A HOLE WAS FOUND IN THE TUBE BODY NEAR THE CONNECTION OF THE INFLATION LINE. THE EVENT OCCURRED DURING TESTING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333077 ↗
• MalfunctionJul 24, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR LEAKAGE. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822020 ↗
• MalfunctionJun 14, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN ANESTHESIOLOGIST INTUBATED A PATIENT WITH A SIZE 7.5 (LOT 4419510) SMITHS MEDICAL PORTEX POLAR PREFORMED NASAL TRACHEAL TUBE FOR FACIO-MAXILLARY SURGERY AND AS IT WAS ATTEMPTED TO INFLATE THE CUFF, IT WAS NOTICED THAT THERE WAS A LEAK AND THEREFORE IT WAS UNABLE TO INFLATE THE CUFF. THE TUBE WAS REMOVED FROM THE PATIENT AND THEN INTUBATED USING A NEW SIZE 7.5 TUBE (LOT 4419510) AND THE SAME ISSUE WAS EXPERIENCED. THEN THE PATIENT WAS INTUBATED WITH A SIZE 7.0 TUBE (LOT 4439675) AND THIS TIME SAME ISSUE WAS EXPERIENCED. CARE WAS TAKEN ON INTUBATION AND NO FORCEPS OR OTHERWISE WERE USED THAT COULD HAVE DAMAGED ANY OF THE CUFFS. FOLLOWING THIS INCIDENT, ALL THREE DEFECTIVE TUBES WERE TESTED UNDERNEATH WATER AND FOUND THAT IN ALL THREE THE LEAK APPEARS TO BE ON THE SEAL OF THE CUFF ITSELF. AFTER DISCUSSING THE INCIDENT IT WAS CONFIRMED BY ANOTHER ANESTHESIOLOGIST THAT SIMILAR ISSUES WERE EXPERIENCED RECENTLY AFTER ATTEMPTING TO INTUBATE WITH MULTIPLE OF THESE TUBES. OTHER TUBES WERE PERSONALLY TESTED FROM THE SAME LOT NUMBERS AND IT APPEARS THAT THE DEFECT IS INCONSISTENT AS SOME ARE DEFECTIVE AND SOME ARE FUNCTIONAL. THE EVENT OCCURRED ON (B)(6) 2024 THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536832 ↗
• MalfunctionMay 23, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DEVICE HAD A PUNCTURED CUFF THAT WAS OBSERVED AFTER IT WAS USED ON THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386186 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A CUFF LEAK. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306244 ↗
• InjuryApr 29, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF RUNS EMPTY AND THERE WAS AN AIR LEAK FROM THE SIDE OF THE CUFF. THE ISSUE OF THE LEAKING CUFF WAS DISCOVERED IN THE OPERATING ROOM AFTER INTUBATION. IT WAS STATED THAT THE PATIENT HAD TO REINTUBATE TWO TIMES, INTUBATED WITH A STRAIGHT TUBE THROUGH THE MOUTH. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM REPORTED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19206614 ↗
• InjuryApr 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF RUNS EMPTY AND THERE WAS AN AIR LEAK FROM THE SIDE OF THE CUFF. THE PATIENT HAD TO REINTUBATED TWO TIMES; INTUBATED WITH A STRAIGHT TUBE THROUGH THE MOUTH. THERE WAS PATIENT INVOLVEMENT AND THERE WAS PATIENT HARM REPORTED. ADVERSE PATIENT EFFECTS ARE UNKNOWN. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION BECAUSE IT WAS THROWN AWAY DUE TO COMING INTO CONTACT WITH PATIENT BODY FLUIDS.

  Patient problems: Insufficient Information

  MAUDE report 19134805 ↗
• MalfunctionMar 19, 2024Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE POLAR NORTH 7.0 TUBE WITH CUFF APPEARED PUNCTURED WITH SIGNIFICANT LEAK DURING MECHANICAL VENTILATION AND INABILITY TO PROPERLY INFLATE THE CUFF. IT WAS INFORMED THAT IT WAS "REPAIRED" DURING THE PROCEDURE. THERE IS NO SAMPLE AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934246 ↗
• InjuryFeb 20, 2024Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE INTUBATION PROCEDURE, IDENTIFIED CUFF WAS PIERCED, REVELED BY A LEAK, RESULTING IN THE NEED TO CHANGE THE DEVICE AND SUBJECTING THE PATIENT TO A NEW INTUBATION. THE PRODUCT WAS NOT REPROCESSED, WAS USED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS IT IS UNKNOWN IF THERE WAS ANYONE HARMED.

  Patient problems: Insufficient Information

  MAUDE report 18743856 ↗
• MalfunctionJan 17, 2024Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE LOST PRESSURE UPON INFLATION OF THE CUFF. NON-REFLUX VALVE IN THE RESERVOIR WAS FAILING. THE USER GOT 2 MORE SIZE 7.0MM TUBES. THE FIRST TUBE DID FAIL, PRIOR TO INSERTION. THE SECOND TUBE HELD FAST. IT WAS THE STAFF NOTICED IMMEDIATELY THAT THE CUFF DEFLATED. THE EVENT OCCURRED ON (B)(6) 2023. THERE WAS A DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. ONE BAG WAS "CONTAMINATED" AS IT WAS INSERTED IN A PATIENT'S AIRWAY PRIOR TO DISCOVERING THE ISSUE. THE OTHER WAS NOT "CONTAMINATED", BUT AS IT WAS TRANSPORTED IN THE SAME BAG. THE CUSTOMER STATES THAT THE TREATMENT OF BOTH BAGS AS "CONTAMINATED". "THE TUBES HAVE ALL COME FROM THE SAME BATCH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527567 ↗
• InjuryOct 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THE CUFF "BREAKS EASILY, EVEN IF IT HAS NOT BEEN TOUCHED". CUSTOMER HAD TO USE "SEVERAL TUBES DURING THE SAME ANESTHESIA". PATIENT INVOLVED , NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958231 ↗
• MalfunctionAug 24, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE CUFF WHILE IN USE WITH THE PATIENT. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17614863 ↗