Portex 101/870/060CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517076196), received between Sep 2, 2020 and Mar 22, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS TRYING TO INFLATE THE CUFF AFTER INSERTING THE TUBE INTO THE PATIENT, THE PILOT BALLOON GOT DETACHED FROM IT. NO INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593206 ↗
• MalfunctionFeb 6, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT. LOT NUMBER 3942246 WAS REPORTED, BUT COULD NOT BE VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308291 ↗
• MalfunctionSep 30, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521904 ↗
• MalfunctionJul 13, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT FOURTEEN (14) DAYS AFTER THE CUSTOMER STARTED TO USE THE PRODUCT, THE INFLATION LINE BECAME DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005616 ↗
• MalfunctionJul 13, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT FOURTEEN (14) DAYS AFTER THE CUSTOMER STARTED TO USE THE PRODUCT, THE INFLATION LINE BECAME DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001145 ↗
• MalfunctionSep 2, 2020Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  INVESTIGATION COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482238 ↗