HEATED HIGH-FLOW TUBE SET 0620050200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056702001568), received between Mar 5, 2019 and Mar 5, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2019Nonstandard Device; Tear, Rip or Hole in Device Packaging; Material Deformation

  DURING A PROCEDURE, A DISPOSABLE HEATED HIGH-FLOW TUBE SET (REF# (B)(4)) WAS USED WHICH SHOWED A KINKING RIGHT AFTER THE INTERFACE FOR CONNECTION TO THE INSUFFLATOR. AFTERWARDS, A SALES REPRESENTATIVE CHECKED THE FACILITY´S INVENTORY OF PACKAGED TUBE SETS AND FOUND OTHER TUBE SETS ALSO SHOWED THIS KINKING. IT WAS REPORTED THAT 4 PACKAGED TUBE SETS WERE KINKED IN SUCH A WAY THAT THE PRONGS OF THE CONNECTION INTERFACE NOW FACE OUTWARD TOWARDS THE PACKAGING AND HAVE LED TO PUNCTURES OF THE POUCH PACKAGING, THUS LEADING TO IMPAIRMENT OF THE STERILE BARRIER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8390527 ↗