FLOW-i C40 6677400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07325710001318), received between Oct 31, 2023 and Apr 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 reports).

4 FDA recall records name this device's identifier, 3 still open.

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.

Recalls naming this device

1. Jun 24, 2026Open, Classified

   Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

   Z-2860-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Dec 11, 2023Open, Classified

   Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

   Z-0989-2024 · Root cause: Software design · FDA record ↗

3. Dec 22, 2022Open, Classified

   Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and hypoxia.

   Z-0959-2023 · Root cause: Software Design Change · FDA record ↗

4. Jan 29, 2021Terminated

   Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.

   Z-1181-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Output Problem

  IT WAS REPORTED THAT THE SYSTEM STOPPED TO DELIVER ANESTHETIC AGENT DURING SOME PART OF THE TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024954 ↗
• MalfunctionMay 15, 2025Failure of Device to Self-Test; Output Problem; Failure of Device to Self-Test; Output Problem

  IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED DURING THE SYSTEM CHECKOUT TEST. ACCORDING TO THE RECEIVED SYSTEM DEVICE LOGS, TWO TECHNICAL ERROR CODES INDICATING AIRWAY PRESSURE SENSOR ERROR HAD BEEN GENERATED. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029138 ↗
• MalfunctionJan 17, 2024Output Problem; Output Problem

  MANUFACTURER'S REF: #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524183 ↗
• MalfunctionNov 6, 2023Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073008 ↗
• MalfunctionOct 31, 2023Output Problem; Output Problem

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038269 ↗