Portex 101/800/075CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019517076080), received between May 24, 2021 and Apr 1, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK. THERE IS ALSO A CONCERN THAT IT MIGHT BE TORN, AS WATER DROPLETS WERE FOUND INSIDE THE CUFF. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758556 ↗
• MalfunctionDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PILOT BALLOON DISLODGED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. POSSIBLE LOT NUMBER 4403463.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825416 ↗
• MalfunctionMay 21, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COULD NOT BE INFLATED. THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS REPORTED AS UNKNOWN. IT WAS UNKNOWN WHETHER THE INCIDENT OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360162 ↗
• MalfunctionSep 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER ATTEMPTED TO INFLATE THE CUFF BUT FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17704204 ↗
• MalfunctionApr 5, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WOULD NOT BE INFLATED. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017348 ↗
• MalfunctionFeb 10, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER FOUND LEAKAGE OF AIR FROM THE CUFF. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508348 ↗
• MalfunctionMay 24, 2021Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS FOUND TO HAVE THE PILOT BALLOON TORN OFF. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872749 ↗