Portex 101/858/060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077834), received between Jul 10, 2024 and Dec 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE SIZE 8 INNER CANNULA WAS NOT LOCKING INTO PLACE. THIS IS A CONTINUATION OF AN ONGOING INVESTIGATION. THE ROOT CAUSE OF THE ISSUES REPORTED WITH THE PREVIOUS LOT NUMBER HAS BEEN IDENTIFIED. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT IN THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THE TUBE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833251 ↗
• MalfunctionJul 10, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE INNER CANNULA WAS NOT CLICKING OR LOCKING INTO PLACE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715283 ↗