Inogen One G5 Oxygen Concentrator - Bluetooth 1260 BluetoothRecalls & reported problems

Summary

The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 00817131020162), received between Aug 10, 2021 and Sep 30, 2026 — classified as 3 deaths, 159 injuries, 73 malfunctions.

The most frequently reported specific device problem is “No Flow” (52 reports).

1 other recall cover devices cleared under the same FDA submission (K032818); they may or may not involve this specific model.

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 25 most recent of 235 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50949319 ↗
• InjurySep 29, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's unit was not producing enough oxygen following a column replacement resulting in the patient having breathing issues. Initial troubleshooting did resolve the issue, however the error persisted a few days after. A replacement unit was sent to the patient as troubleshooting did not resolve the issue the second time. The Inogen Team attempted to contact the patient for further information three times with no response.

  Patient problems: Dyspnea

  MAUDE report 50927193 ↗
• InjurySep 25, 2026Failure to Charge; Unexpected Shutdown

  Patient problems: Dyspnea; Urinary Incontinence

  MAUDE report 50904079 ↗
• InjurySep 25, 2026Premature Discharge of Battery; No Flow

  It was reported that the patient's unit ran out of power earlier than expected. As a result, the patient was not getting oxygen and had to be hospitalized. They were admitted overnight and discharged the next day. A replacement battery was sent to the patient which resolved their issue. Although the issue is with the battery, the patient's unit is the reported device on this report.

  Patient problems: Dyspnea

  MAUDE report 50893082 ↗
• InjurySep 25, 2026Premature Discharge of Battery; Insufficient Flow or Under Infusion

  It was reported that the patient's unit had stopped working earlier than expected. As a result, the patient had trouble breathing. Troubleshooting did not resolve the issue. The patient's family wanted to explore all their options before deciding on a solution. No additional information is available at this time.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50893018 ↗
• InjurySep 24, 2026Failure to Deliver; Noise, Audible; Unexpected Shutdown

  Patient problems: Dyspnea

  MAUDE report 50888946 ↗
• InjurySep 23, 2026Insufficient Flow or Under Infusion

  It was reported that the device was not producing enough oxygen and the patient was experiencing shortness of breath while on vacation. When the patient went on an airplane, they experienced both low oxygen and shortness of breath. Troubleshooting revealed a device column leak. As a result, the patient was hospitalized for 3 days. A replacement device was sent to the patient.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50871430 ↗
• InjurySep 23, 2026Contamination

  It was reported that the patient was hospitalized due to the device being infested with roaches. A replacement device was sent to the patient. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50870901 ↗
• InjurySep 22, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50858768 ↗
• InjurySep 17, 2026Failure to Deliver

  Patient problems: Low Oxygen Saturation

  MAUDE report 50810682 ↗
• InjurySep 16, 2026Overheating of Device; Failure to Deliver

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50796552 ↗
• InjurySep 16, 2026No Flow

  Patient problems: Low Oxygen Saturation

  MAUDE report 50796402 ↗
• InjurySep 15, 2026Failure to Charge; Failure to Power Up; Unexpected Shutdown

  It was reported that the patient's device would shut off by itself and would not turn on. It was noted that the car charger would not work as well. The patient did not have a backup during the event. As a result, the patient experienced shortness of breath until the replacement was received. The patient has no issues with the replacement device.

  Patient problems: Dyspnea

  MAUDE report 50780232 ↗
• InjurySep 15, 2026Failure to Charge; Unexpected Shutdown

  It was reported that the patient's device would shut off by itself after making a noise and that the car charger was not working. As a result, the patient experienced difficulty breathing and was hospitalized. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Dyspnea

  MAUDE report 50776389 ↗
• InjurySep 11, 2026Overheating of Device; No Flow

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50740567 ↗
• InjurySep 1, 2026Failure to Sense

  Patient problems: Dizziness; Dyspnea; Low Oxygen Saturation

  MAUDE report 50551530 ↗
• InjuryAug 31, 2026Connection Problem; Complete Loss of Power

  It was reported that the device had a battery connection defect while the patient was out. As a result, the device stopped working and and the patient had to go to the hospital. A replacement device was sent to the patient. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50531509 ↗
• InjuryAug 31, 2026Failure to Deliver; Noise, Audible

  It was reported that the patient's device was making a weird noise when they were outside their house and the patient was not getting oxygen. It was noted that the "replace columns" message appeared. Troubleshooting was performed and the device stopped making the noise. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50529352 ↗
• InjuryAug 28, 2026Overheating of Device; No Flow; Unexpected Shutdown

  It was reported that the patient's unit was overheating and stopped producing oxygen. As a result, the patient was not receiving enough oxygen and it caused shortness of breath and their heart rate to increase. The patient was able to make it back to their house where they have a backup unit Troubleshooting did not resolve the issue. The patient was sent a replacement unit and it is working for them.

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 50508386 ↗
• InjuryAug 27, 2026Power Problem

  It was reported that the patient's device power supply was having an issue while at a hotel and the pins on the power port seemed to be damaged. The patient did not have a backup device at the time of the event. As a result, the patient was sent to the emergency room and admitted for 6 hours. A replacement device was sent to the patient.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50485204 ↗
• MalfunctionAug 26, 2026Fire

  It was reported that the device's DC Charger caused the device to "pop, causing small damage" in the car. The device was claimed to be burnt. The patient was not injured and did not need to be hospitalized. A replacement device was sent to the patient. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462509 ↗
• InjuryAug 26, 2026Premature Discharge of Battery; Insufficient Flow or Under Infusion

  It was reported that the patient's device was not working properly and the battery was depleting quickly. It caused the patient to experience shortness of breath and their oxygen levels to drop. Patient did not have a backup at the time of the event. As a result, the patient was admitted to the hospital for 15 days. Patient has since been released from the hospital and has received a replacement device.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50457467 ↗
• InjuryAug 25, 2026Failure to Charge; Complete Loss of Power

  It was reported that the battery port of the patient's device was damaged, leading to the device having no power. As a result, the patient was unable to breathe and their oxygen was low. Patient does not have a backup source of oxygen. A replacement device was sent to the patient and they are doing better.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50441746 ↗
• InjuryAug 14, 2026Insufficient Flow or Under Infusion

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 50257557 ↗
• InjuryAug 14, 2026Failure to Run on Battery; No Flow

  Patient problems: Low Oxygen Saturation

  MAUDE report 50255325 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032818. One submission often covers many models, so check the product and lot details in each record.

• Z-1368-05 · Aug 1, 2005 · Terminated
  Portable Oxygen Generator