Portex 101/810/085CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517076318), received between Apr 8, 2024 and Feb 6, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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.

• MalfunctionFeb 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK IN THE DEVICE WAS NOTED DURING THE BALLOON TEST. THE CANNULA WAS STILL PLACED IN THE 68-YEAR-OLD PATIENT BECAUSE THE CANNULA INITIALLY IN PLACE HAD ALREADY BEEN REMOVED. A REMOVAL AND A NEW INSTALLATION TOOK PLACE. AN IDENTICAL REFERENCE DEVICE FROM AN UNKNOWN BATCH WAS USED AS A REPLACEMENT. NO CLINICAL CONSEQUENCES WERE OBSERVED. THIS INCIDENT LED TO THE PROCEDURE BEING REPEATED TWICE. THE DATE OF EVENT IS 10-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326474 ↗
• MalfunctionApr 8, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT WHEN DEFLATING THE CANNULA CUFFS TO REMOVE THEM, THERE WAS A SMALL AMOUNT OF LIQUID IN THE SYRINGE USED TO DEFLATE THE CUFF, CASTING DOUBT ON THE AIRTIGHTNESS OF THE CUFF. THERE WAS PATIENT INVOLVEMENT WITH NO VISIBLE INJURIES, IT WAS ONLY MENTIONED THAT THE PATIENT WAS "MORE CLUTTERED". THE PATIENT DID NOT NEED FURTHER TREATMENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061020 ↗
• MalfunctionApr 8, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT WHEN DEFLATING THE CANNULA CUFFS TO REMOVE THEM, THERE WAS A SMALL AMOUNT OF LIQUID IN THE SYRINGE USED TO DEFLATE THE CUFF, CASTING DOUBT ON THE AIRTIGHTNESS OF THE CUFF. THERE WAS PATIENT INVOLVEMENT WITH NO VISIBLE INJURIES, IT WAS ONLY MENTIONED THAT THE PATIENT WAS "MORE CLUTTERED". THE PATIENT DID NOT NEED FURTHER TREATMENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061006 ↗