Portex 100/136/050Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 15019315021053), received between Jan 4, 2019 and May 5, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (16 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT SEEM TO INFLATE. THE EVENT DID NOT IMPACT THE PATIENT AND/OR THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965007 ↗
• MalfunctionFeb 7, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT AIR COULD NOT GET IN/OUT OF THE CUFF PROPERLY WHILE CHECKING BEFORE USE. THE EVENT OCCURRED DURING PRIMING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333080 ↗
• MalfunctionOct 17, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WON'T INFLATE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471893 ↗
• MalfunctionSep 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PILOT BALLOON COULD NOT INFLATE AIR INTO THE CUFF. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304397 ↗
• MalfunctionJun 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBE NEXT TO THE BLUE LINE FOR CUFF INFLATION. THE HOLE ITSELF IS NOT VISIBLE, BUT IT WAS DETECTED BY THE MACHINE AFTER INTUBATION. THE ERROR WAS REPORTED BY THE VENTILATOR AND THE CLINICIAN HAD TO REINTUBATE THE PATIENT. AFTER CHECKING A FEW OTHER TUBES, THE CUSTOMER FOUND A SIMILAR PROBLEM IN 2-3 SAMPLES. DEVICE IS NOT AVAILABLE FOR INVESTIGATION SINCE THEY DID NOT SAVE THE SAMPLES, BUT A PHOTO WAS PROVIDED. MEDICAL INTERVENTION WAS REQUIRED SINCE THE PATIENT NEEDED TO BE REINTUBATED. THE OUTCOME OF THE EVENT WAS RESOLVED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525133 ↗
• MalfunctionJun 11, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE PROPERLY. THIS OCCURRED AT THE TIME OF UNPACKING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510207 ↗
• MalfunctionMay 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WON'T INFLATE. THIS FAULT OCCURRED BEFORE PATIENT USE/DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315549 ↗
• MalfunctionSep 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING THE CUSTOMER INFLATED THE PRODUCT BUT FELT THAT THE CUFF WAS DIFFICULT TO INFLATE AND DID NOT INFLATE SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761369 ↗
• MalfunctionSep 5, 2023Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT AN AIR LEAK WAS DETECTED, AND A HOLE WAS FOUND IN THE TUBE. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17685465 ↗
• MalfunctionAug 17, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE DEVICE HAD "WEAK CUFF SWELLING". EVEN IF AIR WAS PUT IN WITH A CUFF PRESSURE GAUGE, THE SWELLING OF THE CUFF WAS NOT GOOD. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566077 ↗
• MalfunctionJul 31, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE DEVICE HAD "WEAK CUFF SWELLING". EVEN IF AIR WAS PUT IN WITH A CUFF PRESSURE GAUGE, THE SWELLING OF THE CUFF WAS NOT GOOD. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430923 ↗
• MalfunctionMar 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF WAS UNABLE TO BE INFLATED. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644460 ↗
• MalfunctionJan 6, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WAS UNABLE TO BE DEFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113116 ↗
• MalfunctionAug 30, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER PUT AIR IN THE CUFF AND IT WAS INFLATED AFTER SOME DELAY. ALSO, SIMILARLY, THERE WAS A DELAY BEFORE THE CUFF WAS DEFLATED. THERE IS NO ADDITIONAL INFORMATION FOR THIS COMPLIANT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321262 ↗
• MalfunctionAug 29, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER TRIED TO PUT AIR IN THE CUFF THROUGH THE INFLATION LINE, BUT THE CUFF WOULD NOT BE INFLATED. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15313164 ↗
• MalfunctionAug 29, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF OF THE TRACH TUBE WOULD NOT BE INFLATED. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312748 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY WAS REPORTED *NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278849 ↗
• MalfunctionAug 22, 2022Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN PUTTING AIR IN THE PRODUCT DURING THE PRE-USE CHECK, THE CUSTOMER FELT RESISTANCE THROUGH IT. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265865 ↗
• MalfunctionApr 11, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER FOUND DIFFICULTY INFLATING THE CUFF. NO INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075585 ↗
• MalfunctionApr 5, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE CUSTOMER PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, LEAKAGE FROM THE PRODUCT WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014196 ↗
• MalfunctionJan 31, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WAS UNABLE TO BE INFLATED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13392433 ↗
• MalfunctionApr 30, 2021Inflation Problem; Inflation Problem

  DEVICE EVALUATION COMPLETED AND WILL GENERATED A FOLLOW UP REPORT. JM

  Patient problems: Insufficient Information

  MAUDE report 11752883 ↗
• MalfunctionApr 16, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SYRINGE COULD NOT BE CONNECTED TO THE ONE-WAY VALVE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682176 ↗
• MalfunctionJan 4, 2019Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE HAS A CUFF THAT IS UNABLE TO BE INFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219756 ↗