FLOW-i C20 6677200Recalls & reported problems
Maquet Critical Care AB · Class 2
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Maquet FLOW-i C20 anesthesia machine delivers gases during anesthesia. Reports mostly describe output, pressure or delivery problems during use, with no deaths and 6 injuries among 100 reports. There are 4 recalls, 3 open, about software that can stop ventilation or anesthetic delivery and a possible cybersecurity issue. Reports fell to 11 in the last 12 months from 34 in the prior period.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 99
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07325710001349), received between Mar 3, 2022 and Jun 1, 2026 — classified as 6 injuries, 93 malfunctions.
The most frequently reported specific device problem is “Output Problem” (82 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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-0987-2024 · Root cause: Software design · FDA record ↗
- 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 ↗
- 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
Device problems
- Output Problem82
- Failure of Device to Self-Test4
- Contamination3
- Failure to Deliver3
- Increase in Pressure2
- Infusion or Flow Problem2
- Pressure Problem2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- Low Oxygen Saturation4
- Burn(s)2
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Mechanical Problem
IT WAS REPORTED THAT THE ON/OFF SWITCH ON THE AUXILIARY O2 AND SUCTION UNIT WAS BROKEN. THERE IS NO INFORMATION STATING WHETHER A PATIENT WAS CONNECTED TO THE ANESTHESIA SYSTEM OR NOT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25345744 ↗MalfunctionMar 23, 2026Gas Output Problem; Failure to Deliver
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM, DURING THE PROCEDURE, DID NOT DELIVER THE SET OXYGEN CONCENTRATION. THE PATIENT WAS REMOVED FROM ANESTHESIA SYSTEM AND MOVED TO ANOTHER SYSTEM WHERE THE PROCEDURE CONTINUED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661219 ↗MalfunctionMar 19, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE VENTILATOR GENERATED CLINICAL ALARMS INDICATING INSUFFICIENT VENTILATION DURING TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636529 ↗MalfunctionFeb 11, 2026Increase in Pressure; Gas/Air Leak
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM WHEN IT WAS IN USE GENERATED ALARMS INDICATING A LEAKAGE. ALARMS FOR AIRWAY PRESSURE HIGH WERE FOUND IN THE LOGS. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312171 ↗MalfunctionDec 4, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715013 ↗MalfunctionDec 2, 2025Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT, THE SET PEEP (POSITIVE END EXPIRATORY PRESSURE) LEVEL COULD NOT BE REACHED AND THE SYSTEM REPORTED A LEAKAGE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23691832 ↗MalfunctionNov 26, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED TO DELIVER THE SET FLOW. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23654359 ↗MalfunctionNov 19, 2025Output Problem; Output Problem
IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT, ALARMS INDICATING A LEAKAGE WAS GENERATED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23592543 ↗MalfunctionNov 17, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING AIRWAY PRESSURE SENSOR FAILURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566690 ↗MalfunctionNov 13, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT WAS REPORTED THAT THE SAFETY VALVE TEST FAILED DURING THE SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541230 ↗MalfunctionOct 31, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED IN THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433718 ↗MalfunctionOct 28, 2025Output Problem; Pressure Problem; Output Problem; Pressure Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400944 ↗MalfunctionOct 23, 2025Failure of Device to Self-Test; Failure of Device to Self-Test
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23366184 ↗MalfunctionOct 15, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM GENERATED A TECHNICAL ERROR CODE INDICATING THAT THE SAFETY VALVE WAS OPEN. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23276721 ↗MalfunctionSep 5, 2025Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE VENTILATION STOPPED WHILE THE ANESTHESIA SYSTEM WAS IN USE FOR TREATMENT. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975956 ↗MalfunctionSep 5, 2025Output Problem; Output Problem
IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS IN USE IT GENERATED A TECHNICAL ERROR CODE INDICATING AIRWAY PRESSURE SENSOR ERROR. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975295 ↗MalfunctionSep 3, 2025Failure to Deliver; Failure to Deliver
MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952557 ↗MalfunctionAug 18, 2025Fail-Safe Problem; Output Problem; Fail-Safe Problem; Output Problem
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22824743 ↗MalfunctionAug 1, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685044 ↗MalfunctionJul 28, 2025Decrease in Suction; Output Problem; Decrease in Suction; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM'S AUXILIARY OXYGEN AND SUCTION DEVICE WASN'T ABLE TO CREATE THE LEVEL OF VACUUM AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632017 ↗MalfunctionJul 18, 2025Output Problem; Output Problem
IT WAS REPORTED THAT WHILE THE ANESTHESIA SYSTEM WAS USED FOR TREATMENT, A LEAKAGE OCCURRED. THE PATIENT WAS MOVED TO ANOTHER SYSTEM. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540205 ↗MalfunctionJul 18, 2025Output Problem; Output Problem
MANUFACTURER'S REFERENCE #: (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540112 ↗InjuryJul 2, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM EXHIBITED A CONTINUOUS DECLINE IN SATURATION LEVELS DURING USE. THE EXACT SATURATION VALUES WERE NOT SPECIFIED. THERE WAS NO HARM TO THE PATIENT, AND THE FINAL OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: Low Oxygen Saturation
MAUDE report 22382220 ↗InjuryJul 1, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM EXHIBITED A CONTINUOUS DECLINE IN SATURATION LEVELS DURING USE. THE EXACT SATURATION VALUES WERE NOT SPECIFIED. THERE WAS NO HARM TO THE PATIENT, AND THE FINAL OUTCOME WAS NO INJURY. MANUFACTURER'S REFERENCE #: (B)(4).
Patient problems: Low Oxygen Saturation
MAUDE report 22370207 ↗MalfunctionJun 24, 2025Output Problem; Output Problem
IT WAS REPORTED THAT THE ANESTHESIA SYSTEM FAILED THE PRESSURE TRANSDUCER TEST DURING SYSTEM CHECKOUT AND A TECHNICAL ERROR CODE INDICATING AIRWAY PRESSURE SENSOR ERROR WAS GENERATED. THERE WAS NO PATIENT HARM. MANUFACTURER'S REFERENCE #:(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22319637 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.