Portex 101/800/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517076097), received between Jan 7, 2022 and Oct 19, 2022 — classified as 3 malfunctions.

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

• MalfunctionOct 19, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631638 ↗
• MalfunctionFeb 18, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563277 ↗
• MalfunctionJan 7, 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193586 ↗