Portex 101/860/100CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517076189), received between Mar 15, 2023 and Sep 30, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340089 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE WAS MISSING THE CUFF INFLATION LINE. IT IS USED FOR PATIENTS WHO CANNOT MOVE, AND THE INFLATION LINE CAME OFF WITHOUT APPLYING PRESSURE. NO PATIENT INJURY OR ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17559999 ↗
• MalfunctionJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE INFLATION LINE WAS FOUND DETACHED FROM THE PILOT BALLOON. NO INJURY REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054640 ↗
• MalfunctionApr 25, 2023Separation Problem; Separation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811065 ↗
• MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FIVE (5) DAYS AFTER THE CUSTOMER INTUBATED THE PRODUCT INTO THE PATIENT, THE PILOT BALLOON WAS FOUND DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16548771 ↗