Portex 101/860/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 15019517076172), received between Mar 28, 2021 and Jan 15, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Disconnection” (7 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE AIR GRADUALLY ESCAPES FROM THE CUFF. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079830 ↗
• MalfunctionSep 9, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE SUCTION LINE CONNECTION HAD BECOME DISCONNECTED. 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 23004003 ↗
• MalfunctionAug 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PILOT BALLOON CAME OFF THE INFLATION LINE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22732328 ↗
• MalfunctionAug 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702806 ↗
• MalfunctionNov 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS STATED IN THE REPORT THAT THE CUFF HAD A PINHOLE, SO THE CUFF PRESSURE CANNOT BE KEPT. THE SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE EVENT OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684190 ↗
• MalfunctionNov 14, 2024Leak/Splash; Leak/Splash

  IT WAS STATED IN THE REPORT THAT AIR WAS LEAKING FROM THE CUFF WHILE THE DEVICE WAS IN USE ON THE PATIENT. THE SAMPLE WAS AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683502 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE DECREASES DURING PATIENT USE. THERE IS A POSSIBILITY OF CUFF DAMAGE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184305 ↗
• MalfunctionJul 10, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE DEVICE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714036 ↗
• MalfunctionJun 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PILOT BALLOON AND TUBING WERE TORN. THE EVENT OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472798 ↗
• InjuryMay 20, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS REPLACED ON (B)(6), AND TWO DAYS LATER, IT WAS REPORTED THAT THE CUFF PRESSURE WAS EASILY RELEASED. NORMALLY, THE CUFF PRESSURE WAS CHECKED ONLY IN THE MORNING, BUT IT WAS ALSO CHECKED BEFORE GOING TO BED AND MEASURES WERE TAKEN TO REFIX IT TO 30 CM H2O. AFTER THAT, MEASURES WERE TAKEN IN THE HOSPITAL, BUT THE CUFF PRESSURE WAS STILL LOST, SO THE TUBE WAS REPLACED WITH THE NEXT TUBE ONE WEEK EARLIER THAN PLANNED. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL AND THE EVENT OCCURRED BETWEEN 7-MAR-2024 TO 26-MAR-2024 AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355925 ↗
• InjuryFeb 16, 2024Disconnection; Separation Problem; Disconnection; Separation Problem

  IT WAS REPORTED THAT THE PILOT BALLOON BECAME DETACHED DURING PATIENT USE. THE TRACHEOSTOMY TUBE WAS INSERTED ON SEPTEMBER 15TH. THE PATIENT WAS REMOVED FROM VENTILATOR ON SEPTEMBER 19TH. MOVED TO A CONTROLLED OXYGEN MASK. NURSE VISITED PATIENT ROOM ON OCTOBER 2ND AND FOUND THE PILOT BALLOON DEFLATED AND DISCONNECTED FROM INFLATION LINE. DOCTOR REPLACED THE TUBE AND LIGHT BLOWN COLORED LIQUID (GASTRIC FLUID) COULD BE ASPIRATED. PATIENT INJURY WAS UNKNOWN. HOWEVER ACCIDENTAL SWALLOWING TO THE TRACHEA POSSIBLY OCCURRED ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18724827 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE CONNECTOR AT THE END OF THE SUCTION LINE HAD COME OFF. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18124119 ↗
• MalfunctionAug 2, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THERE WAS CUFF LEAKAGE. SUSPECTED PINHOLE. PATIENT HEALTH EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17443617 ↗
• MalfunctionApr 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER TRIED TO PUT AIR IN THE CUFF BUT COULD NOT. THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY REPORTED. IT HAS BEEN REPORTED THAT NO ADDITIONAL INFORMATION WILL BE AVAILABLE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16810094 ↗
• MalfunctionApr 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER ONE WEEK OF USING THE PRODUCT, THE CUFF WAS DEFLATING EASILY. THE CUFF WAS BEING USED ON AN ALS PATIENT. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735029 ↗
• MalfunctionSep 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456325 ↗
• MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER DID A ROUTINE TRACH CHANGE WITH NO ISSUE DURING THE CHANGE OR THE INITIAL SET UP. ON OR AROUND (B)(6) 2022, THE INFLATION LINE WAS FOUND DETACHED. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438846 ↗
• MalfunctionAug 30, 2022Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT NO ANOMALY WAS FOUND IN THE PRODUCT DURING THE PRE-USE CHECK. HOWEVER, AFTER A WHILE THE CUSTOMER STARTED USING IT, THE CUFF GOT DEFLATED, CAUSING LEAKAGE OF AIR TO OCCUR. ALSO, WHEN HE WAS REFILLING AIR IN THE CUFF EACH TIME LEAKAGE WAS OBSERVED, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322060 ↗
• MalfunctionJul 18, 2022Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON WAS FOUND DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048063 ↗
• MalfunctionJul 18, 2022Break; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE, AN ALARM WENT OFF AND THE INFLATION LINE WAS FOUND DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047892 ↗
• MalfunctionJun 13, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE FAMILY OF THE PATIENT FOUND THAT THE TRACHEOSTOMY TUBE PILOT BALLOON HAD DETACHED. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674881 ↗
• MalfunctionJun 13, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT EIGHT DAYS AFTER USING THIS TRACHEOSTOMY TUBE FROM REGULAR REPLACEMENT, THE CUSTOMER NOTICED THAT THE PILOT BALLOON DETACHED. THE PATIENT WAS BREATHING SPONTANEOUSLY AND DID NOT PULL THE PILOT BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674831 ↗
• MalfunctionJun 7, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE INFLATION LINE GOT DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626223 ↗
• MalfunctionApr 29, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, AN AIR LEAK ALARM WENT OFF. THE TUBE WAS CHANGED TO A NEW ONE. AIR BUBBLES WERE OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250559 ↗
• MalfunctionApr 7, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043774 ↗