ADULT ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT KN6903B-6121ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00612649204673), received between May 8, 2017 and Aug 9, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PER COMPLAINANT: PATIENT DESATTED (DESATURATED) IN THE CV OR DURING THE CASE. THE PATIENT WAS REPORTED TO BE VERY SICK PATIENT; THIS OCCURRED 8-12 HOURS INTO THE CASE WHEN THE PATIENT WAS BEING MOVED/TURNED OVER. ANESTHESIA WAS ABLE TO TAKE A NEW CIRCUIT AND SWITCH OUT THE HME-F AND REPLACE IT WITH A NEW ONE WITH NO PROBLEM. PATIENT IS DOING FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7771110 ↗
• MalfunctionAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PER COMPLAINANT: PATIENT DESATTED (DESATURATED) IN THE CV OR DURING THE CASE. THE PATIENT WAS REPORTED TO BE VERY SICK PATIENT; THIS OCCURRED 8-12 HOURS INTO THE CASE WHEN THE PATIENT WAS BEING MOVED/TURNED OVER. ANESTHESIA WAS ABLE TO TAKE A NEW CIRCUIT AND SWITCH OUT THE HME-F AND REPLACE IT WITH A NEW ONE WITH NO PROBLEM. PATIENT IS DOING FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7771108 ↗
• MalfunctionMay 8, 2017Fracture; Fracture

  AS REPORTED BY THE COMPLAINANT: THE FILTER CRACKED AT THE JUNCTION OF THE ELBOW. THE PATIENT DESATURATED BUT IS DOING FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 6552199 ↗