Portex 101/860/085CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 15019517076165), received between Nov 8, 2020 and May 13, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED AND A CUFF LEAK WAS IDENTIFIED BY THE SURGEON. PER REPORTER, THE TRACHEAL TUBE WAS REPLACED. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161907 ↗
• MalfunctionJan 13, 2025Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE SUCTION CHANNEL OF THE TRACHEOSTOMY TUBE DOES NOT WORK PROPERLY, AND THE SECRETIONS CANNOT BE REMOVED BY SYRINGE OR WITH SUCTION. SLIGHTLY ADJUSTING THE POSITION OF THE CANNULA CORRECTS THE SITUATION LITTLE, BUT USING SALINE OR FLUSHING THE TUBE WITH AIR DOES NOT HELP AT ALL. SEVERAL PATIENTS HAVE HAD THE SAME PROBLEM SINCE THE SUMMER AND CHANGING THE CANNULAS WILL NOT CHANGE THE SITUATION. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141670 ↗
• MalfunctionSep 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE SUCTION CHANNEL OF THE TRACHEOSTOMY TUBE DOES NOT WORK PROPERLY, AND THE SECRETIONS CANNOT BE REMOVED BY SYRINGE OR WITH SUCTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322947 ↗
• MalfunctionJun 19, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT WHEN AIR WAS DRAWN FROM THE CUFF WITH A SYRINGE, THE WATER WAS REMOVED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566871 ↗
• MalfunctionApr 25, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT 2-3 HOURS AFTER INSERTION, THE PILOT BALLOON WAS IN A DIFFERENT STATE THAN NORMAL, AND PRESSURE WAS MEASURED WITH A MANUAL CUFF PRESSURE GAUGE. NO CUFF LEAKAGE WAS FOUND. THIS OCCURRED DURING INFUSION, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181223 ↗
• MalfunctionFeb 27, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "IT WAS TOUGH TO EMPTY THE CAP OF THE PILOT BALLOON." THE EVENT OCCURRED TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793650 ↗
• MalfunctionJan 19, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF. THE CUFF WAS CHECKED BEFORE USE. AFTER PLACEMENT, THE AIR LEAKAGE FROM THE CUFF WAS CHECKED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545843 ↗
• MalfunctionDec 22, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT AIR ESCAPED FROM THE CUFF. WHEN THE CUFF WAS BEFORE USING IT, THE CUFF DEFLATED. DURING THE PATIENT'S INTUBATION, THE CUFF SEEMED TO BE DEFLATED, MAKING IT EASIER FOR THE TUBE TO FALL OUT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384542 ↗
• MalfunctionDec 21, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AIR MISSING DURING PATIENT USE". THE EVENT OCCURRED IN NOV-2023. NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377612 ↗
• MalfunctionMar 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE CUSTOMER CHANGED THE PRODUCT TO ANOTHER ONE FOR REGULAR REPLACEMENT, THE PILOT BALLOON WAS FOUND DETACHED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612813 ↗
• MalfunctionJan 13, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A PINHOLE WAS FOUND IN THE CUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163740 ↗
• MalfunctionDec 29, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067763 ↗
• MalfunctionDec 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE SUCTION LINE CONNECTOR GOT DETACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061103 ↗
• MalfunctionOct 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER TRIED TO PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, BUT IT GOT TORN. THIS EVENT WAS OBSERVED IN THREE (3) PRODUCTS CONSECUTIVELY. THE FOURTH PRODUCT WAS SUCCESSFULLY INFLATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547221 ↗
• MalfunctionSep 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER TRIED TO PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, BUT IT GOT TORN. THIS EVENT WAS OBSERVED IN THREE (3) PRODUCTS CONSECUTIVELY. THE FOURTH PRODUCT WAS SUCCESSFULLY INFLATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498935 ↗
• MalfunctionSep 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER TRIED TO PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, BUT IT GOT TORN. THIS EVENT WAS OBSERVED IN THREE (3) PRODUCTS CONSECUTIVELY. THE FOURTH PRODUCT WAS SUCCESSFULLY INFLATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498578 ↗
• MalfunctionJun 13, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE CUSTOMER PERFORMED A SUCTION THROUGH THE UPPER PART OF THE CUFF DURING USE, THE CONNECTOR AT THE END OF THE SUCTION LINE DETACHED. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674832 ↗
• MalfunctionApr 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER MEASURED THE CUFF PRESSURE, BUT IT WAS BELOW 20CMH2O. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112490 ↗
• MalfunctionApr 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111424 ↗
• MalfunctionMar 24, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER STARTED TO USE THE PRODUCT BY REPLACING FROM THE OLD ONE, AND WHILE IN USE, THE PILOT BALLOON WAS FOUND DETACHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890497 ↗
• MalfunctionFeb 10, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508515 ↗
• InjuryNov 13, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER STARTED USING THE PRODUCT FOR REGULAR REPLACEMENT FOR A PATIENT WITH ENCEPHALITIS. ON OCT/21, THE CUSTOMER NOTICED THE PILOT BALLOON WAS DETACHED FROM THE INFLATION LINE AND HE CHANGED THE PRODUCT TO ANOTHER NEW ONE. IN THE MORNING OF OCT/22, THE PATIENT SUFFERED PNEUMONIA AND WAS UNDERGOING MEDICAL TREATMENT (PNEUMONIA WAS CAUSED BY SECRETION THAT WENT INTO THE LUNG(S)). NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pneumonia

  MAUDE report 12808240 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT MALFUNCTIONED. THE CUSTOMER CONFIRMED THAT THE PRODUCT WORKED PROPERLY IN A PRE-USE CHECK. HOWEVER, DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE INFLATION LINE GOT DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11387139 ↗
• MalfunctionNov 8, 2020Material Separation; Material Separation

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10806588 ↗
• MalfunctionNov 8, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THE DEVICE WAS IN USE AND THE PILOT BALLOON BECAME DETACHED. NO ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10806539 ↗