HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET 0620050350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056702001506), received between Sep 14, 2023 and Jan 21, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• InjuryJan 21, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO OPEN PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21201779 ↗
• MalfunctionSep 14, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "WHEN SHE OPEN THE BOX SHE NOTICED THE TUBE SET HAD A HOLE IN IT". PROBLEM DESCRIPTION PRODUCT #: 620050350. SERIAL/LOT NUMBER: (B)(6). EVENT DATE: (B)(6) 2023. HOW WAS ISSUE NOTICED?: OUT OF BOX FAILURE. PROCEDURE COMPLETED SUCCESSFULLY?: NO ASSOCIATED PROCEDURE. PATIENT INVOLVEMENT?: NO - NO IMPACT. MEDICAL INTERVENTION?: NO ASSOCIATED PROCEDURE. SURGICAL DELAY?: NO. ADVERSE CONSEQUENCES?: NO. ADVERSE CONSEQUENCE DETAILS: NA. PRODUCT AVAILABLE FOR RETURN?: RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743734 ↗