Portex 101/811/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517076356), received between Jun 29, 2023 and Jun 29, 2023 — classified as 3 malfunctions.

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

• MalfunctionJun 29, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE FLANGE WAS BROKEN. THE TUBE HAD BEEN USED BY THE PATIENT FOR THREE (3) WEEKS WHEN IT BROKE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THERE ARE THREE REPORTED EVENTS UNDER (B)(6) AND ALL INVOLVE THE SAME PATIENT. ONLY ONE PATIENT IS INVOLVED IN THESE THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231598 ↗
• MalfunctionJun 29, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE FLANGE WAS BROKEN. THE TUBE HAD BEEN USED BY THE PATIENT FOR THREE (3) WEEKS WHEN IT BROKE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THERE ARE THREE REPORTED EVENTS UNDER (B)(4) AND ALL INVOLVE THE SAME PATIENT; ONLY ONE PATIENT IS INVOLVED IN THESE THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231595 ↗
• MalfunctionJun 29, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE FLANGE WAS BROKEN. THE TUBE HAD BEEN USED BY THE PATIENT FOR THREE (3) WEEKS WHEN IT BROKE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THERE ARE THREE REPORTED EVENTS UNDER (B)(6) AND ALL INVOLVE THE SAME PATIENT. ONLY ONE PATIENT IS INVOLVED IN THESE THREE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231549 ↗