Portex 101/860/060CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15019517076127), received between Aug 12, 2021 and Jan 28, 2026 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT A 7.0 MM ID TUBE WAS INSERTED. THERE WAS A CUFF LEAK. IT WAS REPLACED WITH A 6.0 MM TUBE. WHEN THE REMOVED TUBE CUFF WAS INFLATED IN WATER, A HOLE WAS CONFIRMED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203606 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS STATED THAT A 7.0 MM ID TUBE WAS INSERTED. THERE WAS A CUFF LEAK. IT WAS REPLACED WITH A 6.0 MM TUBE. WHEN THE REMOVED TUBE CUFF WAS INFLATED IN WATER, HOLES WERE CONFIRMED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202785 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS STATED THAT A 7.0 MM ID TUBE WAS INSERTED. THERE WAS A CUFF LEAK. IT WAS REPLACED WITH A 6.0 MM TUBE. WHEN THE REMOVED TUBE CUFF WAS INFLATED IN WATER, HOLES WERE CONFIRMED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202779 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE CUFF CAME OFF WHEN THE PATIENT WAS USING IT. THIS OCCURRED DURING USE AT THE PATIENT'S HOME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797340 ↗
• MalfunctionNov 11, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PILOT BALLOON DEPRESSURIZED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652102 ↗
• MalfunctionJun 28, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK WITH THE CUFF. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634120 ↗
• InjuryMar 26, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF HAD SHRUNK GREATLY OVER TIME. THIS OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979933 ↗
• InjuryMar 26, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF HAD SHRUNK GREATLY OVER TIME. THIS OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979924 ↗
• MalfunctionNov 1, 2023Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER 10 DAYS IN USE FOR THE PATIENT, THE PILOT BALLOON HAD DETACHED FROM THE INFLATION TUBE CONNECTION. WHEN ATTEMPTING TO MEASURE CUFF PRESSURE, THE PILOT BALLOON DETACHED FROM THE INFLATION TUBE CONNECTION, EVEN THOUGH NO SIGNIFICANT FORCE WAS APPLIED. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18048608 ↗
• MalfunctionOct 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT TWELVE DAYS AFTER THE CUSTOMER STARTED TO USE THE PRODUCT, LEAKAGE OF AIR WAS OBSERVED. SO HE CHANGED THE PRODUCT TO ANOTHER NEW ONE. THE CUSTOMER THEN CHECKED THE REMOVED PRODUCT AND FOUND A TEAR IN THE INFLATION LINE, WHICH WAS SUSPECTED TO BE THE ROOT CAUSE OF THE EVENT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12725428 ↗
• MalfunctionAug 12, 2021Crack; Crack

  IT WAS REPORTED THAT THE PATIENT HAD A COUGH THE DAY AFTER STARTING TO USE A TRACHEOSTOMY TUBE. THE PRODUCT WAS REMOVED AND A CRACK WAS FOUND. THE CUSTOMER CHANGED THE TUBE TO A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316397 ↗