Inogen At Home Stationary ConcentratorRecalls & reported problems across all models
Inogen, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 2 models of Inogen At Home Stationary Concentrator by Inogen, Inc. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2021 and Sep 16, 2026 — classified as 34 injuries, 25 malfunctions.
The most frequently reported specific device problem is “No Flow” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Inogen At Home Stationary Concentrator problems
Device problems
- No Flow15
- Insufficient Flow or Under Infusion10
- Output Problem8
- Noise, Audible4
- Overheating of Device4
- Unexpected Shutdown4
- Failure to Deliver3
- Improper Flow or Infusion3
Patient problems
- Dyspnea21
- Low Oxygen Saturation21
- Hypoxia6
- Chronic Obstructive Pulmonary Disease (COPD)4
- No Clinical Signs, Symptoms or Conditions4
- Unspecified Respiratory Problem4
- Cyanosis2
- Burn(s)1
Inogen At Home Stationary Concentrator models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Inogen At Home Stationary ConcentratorGenerator, Oxygen, Portable50 reports
- Inogen At Home Stationary ConcentratorGenerator, Oxygen, Portable9 reports
Recent Inogen At Home Stationary Concentrator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Insufficient Flow or Under Infusion; Noise, Audible
Patient problems: Dyspnea; Fatigue; Low Oxygen Saturation
MAUDE report 50796674 ↗InjurySep 13, 2026Insufficient Flow or Under Infusion
Patient problems: Low Oxygen Saturation
MAUDE report 50747831 ↗MalfunctionSep 9, 2026Degraded; Particulates; Improper Flow or Infusion; Noise, Audible
Device: Inogen At Home oxygen concentrator Prescribed continuous oxygen at flow setting 2 around the clock and setting 4 overnight with BiPAP (ResMed AirCurve 10 ST-A). This serial was shipped (b)(6) 2025 as a NEW warranty advance replacement after refurbished SN (b)(6) failed out of the box (delivered (b)(6) 2025, returned (b)(6) 2025). Prior original (purchased (b)(6) 2022) had also failed with a Level-4 rattle and was replaced. On the night of (b)(6) 2026 the unit developed a sudden abnormal mechanical noise. The noise is audible at setting 2 (continuous therapy) and louder at setting 4 (overnight BiPAP). Itincreases with flow. Particle filter was clean and intake unobstructed (video). Videos ofLevel 2, Level 4, and filter were sent to Inogen. This unit exhibited asudden, flow-dependent mechanical noise at 698 hours -- about 3% of publishedcompressor life -- with a clean filter. That pattern is consistent with prematurecompressor/mechanical failure, not user maintenance error. Around (b)(6) 2026, whileoperating at setting 2, the front panel showed solid yellow warning light, flow indicator#4, and solid blue light, with no beep noticed. Lights were gone the next morning after res
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50690648 ↗InjurySep 2, 2026Insufficient Flow or Under Infusion
Patient problems: Dyspnea
MAUDE report 50572010 ↗InjuryAug 18, 2026Overheating of Device
It was reported that the patient's device was overheating and a System Hot error message was seen. As a result, the patient stopped using the machine and had a "crisis on oxygen." 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 50309625 ↗InjuryAug 12, 2026No Flow
Patient problems: Dyspnea
MAUDE report 50229735 ↗InjuryAug 12, 2026Insufficient Flow or Under Infusion
It was reported that the patient's unit had white dust coming out of the bottom following a column replacement. It was also reported that the unit was not producing enough oxygen for the patient. As a result, the patient had difficulty breathing and was taken to the ER. The patient's oxygen needs may have changed as they decided to go with a higher output machine instead of getting a replacement device.
Patient problems: Dyspnea
MAUDE report 50218119 ↗InjuryAug 11, 2026Insufficient Flow or Under Infusion
It was reported that the patient's device was not producing enough oxygen for the patient and the device was displaying the Low Oxygen error message. As a result, the patient was sent to the hospital and discharged the same day. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.
Patient problems: Unspecified Respiratory Problem
MAUDE report 50216257 ↗InjuryAug 7, 2026Insufficient Flow or Under Infusion
Patient problems: Dyspnea
MAUDE report 50176997 ↗InjuryJul 21, 2026No Flow
IT WAS REPORTED THAT THE PATIENT'S UNIT HAD STOPPED WORKING AND IS NOT PRODUCING OXYGEN FOR THE PATIENT. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED AND THEY BECAME HYPOXEMIC. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND A REPLACEMENT WAS NOT SENT.
Patient problems: Hypoxia; Low Oxygen Saturation
MAUDE report 25898457 ↗InjuryJul 20, 2026Overheating of Device; Failure to Deliver
IT WAS REPORTED THAT THE PATIENT'S STATIONARY DEVICE WAS DISPLAYING THE FIRE HAZARD ALARM AND WAS HAVING TROUBLE BREATHING DURING THE ERROR. 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: Dyspnea
MAUDE report 25882357 ↗InjuryJun 29, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THE PATIENT'S OXYGEN LEVEL HAD DECREASED WITH NEW DEVICE COLUMNS. AS A RESULT, THE PATIENT HAD TO GO TO THE HOSPITAL TO BRING THEIR OXYGEN LEVELS BACK UP. REPLACEMENT COLUMNS WERE SENT 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 25652474 ↗InjuryMay 14, 2026Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE BREATHING WITH THEIR STATIONARY DEVICE DUE TO A SENSOR ISSUE. A REPLACEMENT DEVICE WAS PROVIDED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.
Patient problems: Dyspnea
MAUDE report 25173317 ↗InjuryMar 31, 2026Overheating of Device; Unexpected Shutdown
IT WAS REPORTED THAT THE PATIENT'S DEVICE SHUTDOWN BY ITSELF. THE SYSTEM HOT ERROR MESSAGE WAS PRIOR. AS A RESULT, THE PATIENT WAS WITHOUT OXYGEN FOR A COUPLE OF HOURS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.
Patient problems: Low Oxygen Saturation
MAUDE report 24745141 ↗InjuryMar 26, 2026No Flow; Unexpected Shutdown
IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT STOPPED WORKING AND WAS NOT PRODUCING OXYGEN. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND THERE WAS AN OXYGEN ERROR MESSAGE PRESENT. AS A RESULT, THE PATIENT HAD DIFFICULTY BREATHING AND HAD SHORTNESS OF BREATH. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.
Patient problems: Dyspnea
MAUDE report 24706147 ↗
Other Inogen, Inc. products
All Inogen, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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