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Anesthesia Circuit Kit Flex 6 MP02744Recalls & reported problems

Drägerwerk AG & Co. KGaA · Class 1

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048675412137), received between Sep 24, 2024 and Dec 12, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 3 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture6
  • Gas/Air Leak6
  • Inaccurate Flow Rate3
  • Material Disintegration2
  • Infusion or Flow Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 12, 2024Material Disintegration; Fracture; Gas/Air Leak; Material Disintegration; Fracture; Gas/Air Leak

    IT WAS REPORTED THE BREATHING CIRCUIT BROKE AT THE FLEX POINT STRAIGHT THROUGH THE TUBING. NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20910941 ↗
  • MalfunctionDec 12, 2024Material Disintegration; Fracture; Gas/Air Leak; Material Disintegration; Fracture; Gas/Air Leak

    IT WAS REPORTED THE BREATHING CIRCUIT BROKE AT THE FLEX POINT STRAIGHT THROUGH THE TUBING. NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20910932 ↗
  • MalfunctionOct 15, 2024Fracture; Gas/Air Leak; Infusion or Flow Problem; Fracture; Gas/Air Leak; Infusion or Flow Problem

    CIRCUIT TORE, PATIENT WAS BAGGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20448352 ↗
  • MalfunctionSep 24, 2024Inaccurate Flow Rate; Fracture; Gas/Air Leak; Inaccurate Flow Rate; Fracture; Gas/Air Leak

    CIRCUIT TORE MID CASE - PATIENT BAGGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20289335 ↗
  • MalfunctionSep 24, 2024Inaccurate Flow Rate; Fracture; Gas/Air Leak; Inaccurate Flow Rate; Fracture; Gas/Air Leak

    CIRCUIT TORE MID CASE - PATIENT BAGGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20289331 ↗
  • MalfunctionSep 24, 2024Inaccurate Flow Rate; Fracture; Gas/Air Leak; Inaccurate Flow Rate; Fracture; Gas/Air Leak

    CIRCUIT TORE MID CASE - PATIENT BAGGED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20289330 ↗

Other Anesthesia Breathing Circuit Kit (Adult & Pediatric) devices

All Anesthesia Breathing Circuit Kit (Adult & Pediatric) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.