Portex 100/133/060Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 15019315020339), received between Apr 6, 2017 and Jul 8, 2026 — classified as 20 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (20 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 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747914 ↗
• MalfunctionApr 23, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEAL TUBE CUFF DEFLATED IMMEDIATELY UPON RE-INTUBATION, FOLLOWING A SIMILAR FAILURE AND REQUIRING THE PATIENT A TOTAL OF FOUR TIMES, THREE MORE TIMES FOLLOWING THIS INCIDENT. ACCORDING TO THE REPORTER, DURING A STOMATOLOGICAL PROCEDURE, A SIZE 6.0 TRACHEAL TUBE WAS USED FOR LEFT NASAL INTUBATION VIA THE LEFT NOSTRIL WITH THE ASSISTANCE OF A VIDEO LARYNGOSCOPE. PASSAGE THROUGH THE NASAL TURBINATES WAS ACHIEVED WITHOUT DIFFICULTY. INTUBATION WAS DESCRIBED AS EASY, WITH GOOD VISUALIZATION OF THE VOCAL CORDS, AND MAGILL FORCEPS WERE NOT UTILIZED. THE REPORTER STATED THAT DURING ATTEMPTED CUFF INFLATION, INFLATION FAILURE WAS OBSERVED, AS THE CUFF PROGRESSIVELY DEFLATED DURING INFLATION. PER THE ANESTHESIOLOGIST, NO ISSUE WAS IDENTIFIED WITH THE CUFF VALVE. THE INITIAL TUBE WAS REPLACED WITH A SECOND TUBE OF THE SAME TYPE AND SIZE; HOWEVER, THE SAME CUFF DEFLATION ISSUE WAS OBSERVED. A THIRD TUBE CHANGE WAS THEN PERFORMED USING A REINFORCED (ARMORED) SIZE 5.5 TUBE. INTUBATION WAS SUCCESSFUL; HOWEVER, THE CUFF DEFLATION ISSUE PERSISTED. A FOURTH TUBE, A REINFORCED TUBE OBTAINED FROM THE EQUIPMENT RESERVE, WAS SUBSEQUENTLY USED, AND THE REPORTED ISSUE DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965603 ↗
• MalfunctionOct 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATED POORLY, DIFFICULTY REMOVING THE CATHETER. INCIDENT OCCURRED DURING USE. PATIENT CONSEQUENCES: DIFFICULTY OF REMOVAL, LONG TIME INTERVENTION AND PAINFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354305 ↗
• MalfunctionAug 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PROCESS OF INFLATING THE DEVICE, THE DOCTOR FOUND THAT THE AIRBAG WAS LEAKING, THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853929 ↗
• MalfunctionAug 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PATIENT'S OPERATION, AIR KEPT COMING UP FROM THE THROAT, SO THE DEVICE WAS REPLACED AND THE OPERATION PROCEEDED. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783014 ↗
• MalfunctionAug 7, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE PILOT CUFF DEFLATED. THERE WAS PATIENT INVOLVEMENT. THE OPERATOR OF THE DEVICE WAS A HEALTHCARE PROFESSIONAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741846 ↗
• MalfunctionAug 7, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH THE DEVICE WITHOUT ANY ISSUES. AFTERWARDS, THE CUFF DEFLATED AFTER BEING INFLATED. THERE WAS PATIENT INVOLVEMENT. THE RELEVANT TREATMENT IN PROGRESS AT TIME OF INCIDENT WAS THE ANESTHETIC INFUSION. THE OPERATOR OF THE DEVICE WAS A HEALTHCARE PROFESSIONAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741736 ↗
• MalfunctionAug 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF INFLATED, BUT THE PILOT BALLOON DID NOT." THE EVENT OCCURRED DURING PATIENT IN USE/DOSE. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733122 ↗
• MalfunctionJul 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BALLOON OF THE FACIAL TUBE CUFF PRESENTED A HOLE DURING INTUBATION, REQUIRING A NEW INTUBATION AND TUBE REPLACEMENT. THIS EVENT WAS CLASSIFIED AS CRACKED, COMPLETELY BROKEN OR PARTIALLY BROKEN AT THE REPORT ON PRODUCT ALTERATIONS FIELD. THE EVENT OCCURRED IN THE OPERATION ROOM, DURING TREATMENT. ALTHOUGH IT OCCURRED DURING USE WITH A PATIENT, THERE WAS NO DELAY IN THE THERAPY AND NO HARM REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564661 ↗
• MalfunctionJun 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUFF WAS PUNCTURED, A NEW INTUBATION ATTEMPT WAS MADE IN PATIENT, HOWEVER THE NEW CANNULA WAS WITH THE CUFF ALSO PUNCTURED. EVENT OCCURRED WHILE USE IN PATIENT. THERE WAS NO PATIENT HARM. CUSTOMER REFERENCE IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145540 ↗
• MalfunctionJun 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUFF WAS PUNCTURED, A NEW INTUBATION ATTEMPT WAS MADE IN PATIENT, HOWEVER THE NEW CANNULA WAS WITH THE CUFF ALSO PUNCTURED. EVENT OCCURRED WHILE USE IN PATIENT. THERE WAS NO PATIENT HARM. CUSTOMER REFERENCE IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145491 ↗
• MalfunctionMay 30, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF DID NOT SEEM TO HOLD ITS PRESSURE SO THE PATIENT COULD NOT BE ANESTHETIZED APPROPRIATELY. THE CARE TEAM APPLIED A MANOMETER TO THE PILOT BALLOON TO ASSESS CUFF PRESSURE, BUT THE PRESSURE SEEMED TO DROP WHICH CAUSED THE TUBE TO BE SWAPPED. AFTER INSPECTION OF TUBES, NO DAMAGE WAS FOUND TO THE CUFF THEREFORE NO APPARENT REASON FOR CUFF TO BE DEFLATED. THERE IS NO REPORTED PATIENT INVOLVEMENT AND/OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117780 ↗
• MalfunctionMay 30, 2025Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF DID NOT SEEM TO HOLD ITS PRESSURE SO THE PATIENT COULD NOT BE ANESTHETIZED APPROPRIATELY. THE CARE TEAM APPLIED A MANOMETER TO THE PILOT BALLOON TO ASSESS CUFF PRESSURE, BUT THE PRESSURE SEEMED TO DROP WHICH CAUSED THE TUBE TO BE SWAPPED. AFTER INSPECTION OF TUBES, NO DAMAGE WAS FOUND TO THE CUFF THEREFORE NO APPARENT REASON FOR CUFF TO BE DEFLATED. THERE IS NO REPORTED PATIENT INVOLVEMENT AND/OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117392 ↗
• MalfunctionMay 12, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT AIR INSERTED INTO THE CUFF TO CREATE A TRACHEAL SEAL GRADUALLY DEFLATES, LEADING TO LOSS OF SEAL AND A SUBSEQUENT LEAK. THEREFORE, THE PATIENT CANNOT BE VENTILATED APPROPRIATELY. THERE IS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003231 ↗
• InjuryDec 12, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A NASAL TRACHEAL END PROBE WAS PERFORMED WITH BALLOON SIZE 6. THE BALLOON WAS PIERCED, PROBE REMOVED (AND THROWN AWAY), AND INSTALLATION OF A SECOND PROBE WAS PERFORMED. AGAIN, THERE WAS OBSERVATION OF A PIERCED BALLOON. THE SECOND PROBE WAS KEPT (SOILED). THREE TUBES WERE PLACED TO ALLOW THE PATIENT TO BE INTUBATED. INSTALLATION OF THE THIRD PROBE OCCURRED WITHOUT ANY PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913545 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ONCE IN THE TUBE WAS IN THE PATIENT AND THE CUFF WAS INFLATED, THERE WAS A MASSIVE AIR LEAK. THE ANESTHETIST COULD NOT ADEQUATELY VENTILATE THE PATIENT. THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT THE LEAK WAS ORIGINATING FROM THE TUBE, BUT THE TUBE CUFF WAS NOT COMPROMISED. THE LEAK WAS OCCURRING AT THE VALVE WHERE THE AIR WAS INTRODUCED INTO THE TUBE TO INFLATE THE CUFF. THIS VALVE ISSUE RESULTED IN AIR LEAKAGE FROM THE BALLOON AND CUFF OF THE TUBE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798542 ↗
• MalfunctionJun 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT HOLD INFLATION PRESSURE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608709 ↗
• MalfunctionJun 13, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON DEFLATES DURING INTUBATION. THE SAME PATIENT WAS INTUBATED AND EXTUBATED THREE TIMES. THE PROBES HAD TO BE REPLACED WITH A NEW ONE FROM A DIFFERENT BATCH. THERE WAS PATIENT INVOLVEMENT. NO HARM/ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532727 ↗
• MalfunctionMay 13, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A POST-INTUBATION PROBLEM WITH THE CUFF DEFLATING ON TWO CONSECUTIVE PROBES WITH TWO DIFFERENT SIZES (6 AND 6.5)". THERE WAS A PATIENT INVOLVED, AND THE CONSEQUENCES OF THE EVENT WERE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19300381 ↗
• MalfunctionApr 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER 30 MINUTES OF INTUBATION, THE PRESENCE OF BUBBLES IN THE MECHANICAL VENTILATION CAUSED MOUTH BLEEDING. IT WAS OBSERVED THAT THERE WAS A LEAK ON THE PROXIMAL SEAL OF THE PROBE. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19134087 ↗
• MalfunctionApr 5, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE, DESPITE 10 CC OF AIR INSUFFLATED WITH A SYRINGE AND THE VALVE APPEARING FUNCTIONAL. THIS OCCURRED WHILE CHECKING THE INTUBATION TUBE BEFORE THE PATIENT'S ANESTHETIC INDUCTION. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051690 ↗
• MalfunctionMar 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WAS PUNCTURED EVEN BEFORE BEING USED. THE MALFUNCTION WAS IDENTIFIED IN THE PRE-USE TEST BEFORE PLACEMENT BY THE DOCTOR. THERE IS A SAMPLE AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861654 ↗
• MalfunctionFeb 20, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AT THE SURGERY CENTER, THE NASAL TUBE BALLOON WAS PUNCTURED. THE PRODUCT WAS NOT REPROCESSED, WAS USED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18743414 ↗
• MalfunctionFeb 8, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE DENTAL LIST THEY ENCOUNTERED A PROBLEM WITH THE SIZE SIX NASAL TUBES. ONCE INSERTED THE BALLOONS DEFLATED ON FOUR SEPARATE TUBES, THREE OF WHICH CAME FROM THE SAME LOT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS.

  Patient problems: Insufficient Information

  MAUDE report 18671359 ↗
• MalfunctionFeb 7, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE DENTAL LIST THEY ENCOUNTERED A PROBLEM WITH THE SIZE SIX NASAL TUBES. ONCE INSERTED THE BALLOONS DEFLATED ON FOUR SEPARATE TUBES, THREE OF WHICH CAME FROM THE SAME LOT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS.

  Patient problems: Insufficient Information

  MAUDE report 18660616 ↗