Inogen One G3 Oxygen Concentrator 1050 (REF IO-300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00817131020063), received between Oct 28, 2020 and Sep 24, 2026 — classified as 2 deaths, 73 injuries, 36 malfunctions.

The most frequently reported specific device problem is “No Flow” (22 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 111 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Smoking

  Patient problems: Dyspnea

  MAUDE report 50890099 ↗
• InjurySep 22, 2026Temperature Problem; Unexpected Shutdown

  Patient problems: Presyncope

  MAUDE report 50860259 ↗
• InjurySep 21, 2026Failure to Deliver

  Patient problems: Dyspnea; Fall; Syncope/Fainting

  MAUDE report 50849236 ↗
• InjurySep 18, 2026Failure to Charge; Failure to Run on Battery

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50822569 ↗
• InjurySep 17, 2026Overheating of Device; Unexpected Shutdown

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50811036 ↗
• InjuryAug 25, 2026Insufficient Flow or Under Infusion

  Patient problems: Dyspnea

  MAUDE report 50442239 ↗
• MalfunctionAug 12, 2026Overheating of Device; No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229605 ↗
• InjuryAug 5, 2026Failure to Run on Battery

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50148563 ↗
• InjuryAug 3, 2026Overheating of Device; Unexpected Shutdown

  Patient problems: Dyspnea

  MAUDE report 50118031 ↗
• InjuryAug 3, 2026Device Emits Odor; Overheating of Device

  It was reported that the patient's device was overheating and a burning smell was noted. The patient stated they were hospitalized due to the event. A replacement device was sent. No additional information is available at this time as attempt to follow-up with the patient for more information was unsuccessful.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50117518 ↗
• MalfunctionAug 3, 2026Sparking; No Flow

  It was reported that the patient's unit sparked when they tried charging it near the charging port. As a result, the unit stopped working and was not producing any oxygen. There were no patient health changes. A replacement unit was sent to the patient. The Inogen Team attempted to contact the patient for further information three times with no response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50110602 ↗
• MalfunctionJul 28, 2026Sparking

  It was reported that the patient saw sparks at the device's charging port when plugged in. There were no patient health changes due to the event. The patient used their stationary unit after. The patient has received their replacement device with no issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059401 ↗
• InjuryJul 27, 2026Premature Discharge of Battery; Failure to Charge

  It was reported that the device was not charging while plugged in at a court house and the device battery was also not lasting as long as expected. As a result, the device ran out of power and the patient passed out due to being without oxygen. The patient was taken to the hospital and put on life support. The patient has since been released and received their replacement device.

  Patient problems: Syncope/Fainting

  MAUDE report 50046428 ↗
• InjuryJul 19, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT STOPPED WORKING AND WAS NOT PRODUCING ENOUGH OXYGEN. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND LATER ADMITTED TO THE HOSPITAL. THEY WERE DISCHARGED AFTER THREE DAYS AND THEY ARE RECOVERING. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM.

  Patient problems: Dyspnea

  MAUDE report 25867274 ↗
• InjuryJul 16, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT WHEN THE PATIENT WENT TO GO TO THEIR APPOINTMENT, THE PATIENT FELT LIKE THEY WERE SUFFOCATING WHILE USING THE DEVICE. NO ERROR MESSAGES WERE SEEN ON THE DEVICE. AS A RESULT, THE PATIENT WAS SENT TO THE HOSPITAL EMERGENCY ROOM AND WAS PUT ON THEIR OXYGEN. WHEN THE PATIENT LEFT TO THEIR VEHICLE, THE PATIENT STARTED FEELING LIKE THEY WERE SUFFOCATING AGAIN SO THEY WERE PUT ON THE HOSPITAL OXYGEN AGAIN. THE PATIENT WAS SENT HOME WITH AN OXYGEN TANK GIVEN. PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT.

  Patient problems: Dyspnea

  MAUDE report 25846656 ↗
• InjuryJul 1, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS OVERHEATING AND FELT HOT TO THE TOUCH. AS A RESULT, THE UNIT LEFT A MARK ON THE PATIENT'S PALM WHEN THEY WERE HANDLING IT. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Burn(s)

  MAUDE report 25679860 ↗
• InjuryJun 29, 2026Failure to Deliver

  IT WAS REPORTED THAT WHEN THE PATIENT WENT ON A TRIP, THE PATIENT'S DEVICE STOPPED WORKING AT A HOTEL. LATER, THE PATIENT'S OXYGEN LEVELS HAD DROPPED TO 69% WHILE USING THE DEVICE. AS A RESULT, THE PATIENT'S DAUGHTER CALLED 911 WHERE THE PATIENT WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL, BUT WAS PUT ON OBSERVATION UNTIL A REPLACEMENT DEVICE WAS RECEIVED. PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT DEVICE AND LEFT THE HOSPITAL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25653186 ↗
• InjuryJun 24, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S UNIT OVERHEATED AND SHUT DOWN WHILE THE PATIENT WAS OUT WALKING. AS A RESULT, THE PATIENT'S OXYGEN HAD DROPPED AND THEY CALLED EMERGENCY SERVICES WHO PROVIDED SUPPLEMENTAL OXYGEN AND A RIDE BACK TO THE PATIENT'S HOUSE. THE PATIENT HAS A STATIONARY UNIT AT HOME THAT THEY WERE ABLE TO USE WHILE WAITING FOR A REPLACEMENT. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25603862 ↗
• InjuryMay 27, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT POWERING ON WHEN THEY ARRIVED AT A DOCTOR'S APPOINTMENT AND THE PATIENT'S OXYGEN LEVELS DROPPED. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL. A REPLACEMENT DEVICE WAS SHIPPED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25303427 ↗
• InjuryMay 22, 2026Failure to Charge

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT CHARGING AND THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT HAS A STATIONARY OXYGEN CONCENTRATOR THAT THEY CAN USE. IT IS UNCONFIRMED IF THE REASON FOR HOSPITALIZATION WAS DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 25260142 ↗
• InjuryMay 22, 2026Failure to Charge

  IT WAS REPORTED THAT THE PATIENT'S UNIT WOULD NOT CHARGE. AS A RESULT, THE PATIENT WAS HOSPITALIZED. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 25255887 ↗
• InjuryMay 21, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S DEVICE KEPT TURNING OFF BY ITSELF WHILE DRIVING, LEADING TO THE PATIENT EXPERIENCING SHORTNESS OF BREATH AND LOWERED OXYGEN CONCENTRATION. AS A RESULT, THE PATIENT DROVE TO ER WHERE THEY WERE ADMITTED FOR A COUPLE OF HOURS. DURING THE ER VISIT, TROUBLESHOOTING WAS PERFORMED BY CONNECTING AND RECONNECTING THE BATTERY, WHICH HELPED THE ISSUE. PATIENT HAS SINCE BEEN RELEASED FROM THE ER AND RECEIVED THEIR REPLACEMENT DEVICE.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 25248949 ↗
• InjuryMay 14, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT FELL GETTING OUT OF THEIR TRUCK WITH THE DEVICE. TROUBLESHOOTING DISPLAYED THE SYSTEM HOT ERROR MESSAGE. IT WAS NOTED THAT THE PATIENT WAS 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: Fall

  MAUDE report 25176124 ↗
• InjuryMay 14, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT PRODUCING OXYGEN WHEN PLUGGED INTO THE POWER SUPPLY AND THE PATIENT WAS HOSPITALIZED. A REPLACEMENT DEVICE WAS SENT OT 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 25173957 ↗
• InjuryApr 27, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD A LOW OXYGEN ERROR MESSAGE AND WAS NOT OUTPUTTING ENOUGH OXYGEN. AS A RESULT, THE PATIENT HAD TO BE HOSPITALIZED AS THEY DID NOT HAVE ANOTHER SOURCE OF OXYGEN WITH THEM. A REPLACEMENT UNIT WAS SENT TO THE PATIENT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25008553 ↗

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