Portex 100/133/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 15019315020360), received between Sep 5, 2018 and Aug 28, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED THAT AFTER NASAL INTUBATION, THERE WAS A CUFF LEAK AND CAMERA FOGGING, SO THE TUBE WAS REPLACED. AFTER REPLACEMENT, THE PREVIOUSLY USED TUBE WAS CHECKED, AND AIR LEAKAGE FROM THE CUFF WAS CONFIRMED. THE AIRWAY WAS MAINTAINED, AND THERE WAS NO IMPACT ON THE RESPIRATORY CONDITION. 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 22913070 ↗
• MalfunctionFeb 6, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PRODUCT PRESENTED A PUNCTURED CUFF. NO OCCURRENCE OF THE SAME TYPE CAUSED OR CONTRIBUTED TO DEATH OR SERIOUS DAMAGE TO HEALTH IN THE LAST TWO YEARS PER THE HISTORICAL DATA FROM THE USER FACILITY. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, ANY INJURY, HARM, OR ADVERSE EVENT AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323633 ↗
• InjuryJun 14, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN ANESTHESIOLOGIST INTUBATED A PATIENT WITH A SIZE 7.5 TUBE FOR FACIO-MAXILLARY SURGERY, AND WHILE ATTEMPTING TO INFLATE THE CUFF, IT WAS NOTICED THAT THERE WAS A LEAK. THE TUBE WAS REMOVED FROM THE PATIENT AND THEN INTUBATED USING A NEW SIZE 7.5 TUBE AND THE SAME ISSUE WAS EXPERIENCED. THE PATIENT WAS INTUBATED WITH A SIZE 7.0 TUBE AND THE 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 ALL THREE LEAKS APPEARED TO BE ON THE SEAL OF THE CUFF ITSELF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536949 ↗
• InjuryDec 14, 2023Tidal Volume Fluctuations; Gas/Air Leak; Tidal Volume Fluctuations; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A "LOSS OF TIDAL VOLUME DURING GENERAL ANESTHESIA. BALLOON PRESSURE WAS MAINTAINED. VOLUME OCCURS SEVERAL TIMES WITH BALLOON FLAT.DECISION TO REINTUBATE FOR FURTHER SURGERY AND INTUBATION, WHICH WILL LAST A MINIMUM OF 24 HOURS". THE CUSTOMER SAID THAT THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. NO CLINICAL CONSEQUENCES FOR THE PATIENT AND NO MEDICAL TREATMENT. INTERRUPTION OF SURGERY FOR 20 MINUTES DURING REINTUBATION ON GUIDE. NEED FOR RE-INTUBATION ON GUIDE DURING THE PROCEDURE DUE TO BALLOON LEAK, WITHOUT "DIFFICULTY". THE OUTCOME OF THE INJURY WAS REPORTED AS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326506 ↗
• MalfunctionNov 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE POST INTUBATION, A LEAK IN THE CUFF WAS NOTED, AND NO IMPROVEMENT. IT WAS REMOVED FROM PATIENT AND ANOTHER TUBE WAS INSERTED. PRODUCT WAS TESTED IN CONTAINER OF WATER AND LEAK WAS FOUND AT THE SYRINGE CONNECTING SITE. NO PATIENT INJURY PER HOSPITAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794292 ↗
• MalfunctionSep 15, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUSTOMER WAS DISSATISFIED WITH THE PRODUCT DIMENSIONS. THERE WAS INSUFFICIENT ANGULATION, AND IT WAS ALSO COMPLAINED THAT THE NORTH/SOUTH TUBES WERE NOT AT A GREAT ENOUGH ANGULATION. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432144 ↗
• MalfunctionSep 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND A STAIN ON THE PRODUCT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362694 ↗
• MalfunctionJun 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NURSE FOUND CUFF LEAKED WHILE TESTING PROCESS. NO INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802441 ↗
• MalfunctionOct 30, 2020Inflation Problem; Inflation Problem

  (PLEASE SEE CC-0088903 FOR ALL ATTACHMENTS AND FOLLOW UPS) CUFF FAILED TO INFLATE IN 4 CONSECUTIVE NASAL ENDOTRACHEAL TUBES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10766663 ↗
• MalfunctionOct 30, 2020Inflation Problem; Inflation Problem

  LOT NUMBER PROVIDED. NO PRODUCT WAS RETURNED AND INVESTIGATION BASED ON SAMPLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10764419 ↗
• MalfunctionOct 30, 2020Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION ON LOT NUMBER 3858243.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10764366 ↗
• MalfunctionOct 30, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THE DEVICE CUFF DID NOT INFLATE. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10764029 ↗
• MalfunctionFeb 9, 2020Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED THAT AT THE TIME OF ANESTHESIA A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE HAD A BALLOON PUNCTURED AND NEEDED TO BE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9685073 ↗
• MalfunctionOct 11, 2018Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING INTUBATION OF THE PATIENT WITH A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE, AIR CAME OUT OF THE CUFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7958675 ↗
• MalfunctionOct 11, 2018Deflation Problem; Deflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING INTUBATION OF THE PATIENT WITH A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE, AIR CAME OUT OF THE CUFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 7958630 ↗
• MalfunctionOct 10, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING INTUBATION OF THE PATIENT WITH A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE, AIR CAME OUT OF THE CUFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952227 ↗
• MalfunctionSep 5, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING INTUBATION OF THE PATIENT WITH A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE, AIR CAME OUT OF THE CUFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845546 ↗