Inogen At Home Stationary ConcentratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00817131020148), received between Aug 10, 2021 and Sep 16, 2026 — classified as 30 injuries, 20 malfunctions.

The most frequently reported specific device problem is “No Flow” (12 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, 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 50 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMar 20, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT WAS DISPLAYING AN ERROR MESSAGE RELATED TO PRESSURE. AS A RESULT, THE PATIENT HAD SHORTNESS OF BREATH DUE TO NOT GETTING ENOUGH OXYGEN FROM THE UNIT. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THERE WAS A FINE WHITE POWDER ON THE COLUMNS INSIDE THE UNIT. 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: Dyspnea

  MAUDE report 24654769 ↗
• InjuryMar 11, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT WAS NOT PRODUCING OXYGEN THROUGH THE NIGHT. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED TO THE 60S AND THE PARAMEDICS HAD TO BE CALLED TO ADMINISTER SUPPLEMENTAL OXYGEN. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24571277 ↗
• InjuryMar 10, 2026No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS DISPLAYING AN ERROR CODE CAUSING THE UNIT TO NOT WORK PROPERLY. IT WAS REPORTED THAT THE UNIT HAD BEEN HAVING THE ISSUE FOR APPROXIMATELY TWO MONTHS. THE PATIENT STATED THAT THEY HAD TO GO TO THE HOSPITAL DUE TO NOT RECEIVING OXYGEN FROM THE UNIT. DUE TO LOW OXYGEN LEVELS, EMERGENCY SERVICES WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THEY WERE DISCHARGED A FEW DAYS LATER. THEY BORROWED A FRIEND'S UNIT WHILE WAITING FOR A REPLACEMENT AT THE TIME. A REPLACEMENT UNIT HAS BEEN SENT TO THE PATIENT AND IT IS WORKING WELL FOR THEM AT THIS TIME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24558861 ↗
• InjuryJan 27, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS NOT PRODUCING ENOUGH OXYGEN AND THE PATIENT WAS NOT GETTING ENOUGH OXYGEN. AS A RESULT, THE PATIENT NOTED THAT THEIR HANDS STARTED TO TURN BLUE. THE UNIT STARTED WORKING AGAIN AND THEIR HANDS WENT BACK TO NORMAL. THEY DID NOT HAVE TO BE HOSPITALIZED DUE TO THE EVENT. THEY RECEIVED THEIR REPLACEMENT AND IT IS WORKING FOR THEM.

  Patient problems: Cyanosis

  MAUDE report 24192600 ↗
• InjuryJan 5, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT PRODUCING ENOUGH OXYGEN FOR THEM. IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVELS WERE DECREASING AND WERE HAVING TROUBLE BREATHING. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS A RESULT, THE PATIENT WAS HOSPITALIZED DUE TO THE ISSUE EXACERBATING THEIR LUNG CONDITION (PULMONARY FIBROSIS). A REPLACEMENT DEVICE HAS BEEN SENT TO THE PATIENT AND THE PATIENT HAS LEFT THE HOSPITAL SINCE IT WAS RECEIVED.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 23967235 ↗
• InjuryDec 5, 2025No Flow; Unexpected Shutdown; No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT STOPPED WORKING. IT WAS BEEPING AND THERE WAS A FINE WHITE DUST COMING FROM THE UNIT. AS A RESULT, THE PATIENT'S OXYGEN SATURATION LEVELS HAD DROPPED SIGNIFICANTLY CAUSING THEIR FINGERS TO TURN BLUE AND CAUSING THEM TO FEEL DISORIENTED. THEY WERE UNABLE TO ACCESS THEIR BACKUP PORTABLE UNIT, HOWEVER THE PATIENT'S SON PROVIDED A BACKUP OXYGEN SOURCE TO ENSURE THE PATIENT GOT ENOUGH OXYGEN. THE PATIENT DID NOT HAVE TO GO THE HOSPITAL NOR DID THEY HAVE TO CONTACT EMERGENCY SERVICES. THE PATIENT HAS RECEIVED A REPLACEMENT UNIT AND IT IS WORKING WELL FOR THEM.

  Patient problems: Confusion/ Disorientation; Cyanosis; Low Oxygen Saturation

  MAUDE report 23729298 ↗
• InjuryNov 26, 2025Temperature Problem; Noise, Audible; Temperature Problem; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE UNIT WAS PRODUCING A LOUD GRINDING NOISE AND WAS GETTING A LITTLE WARM. THEY ALSO STATED THAT THE AIR THEY WERE BREATHING IN CAUSED THEM TO COUGH AND MADE THEIR THROAT BURN. AS A RESULT, THE PATIENT WAS HOSPITALIZED WHERE THEY WERE PROVIDED SUPPLEMENTAL OXYGEN. 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: Burning Sensation; Cough

  MAUDE report 23660287 ↗
• InjuryNov 20, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT'S STATIONARY UNIT HAD CUT OFF IN THE MIDDLE OF THE NIGHT. AS A RESULT, THE PATIENT WAS HOSPITALIZED. NO FURTHER INFORMATION IS AVAILABLE. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23611353 ↗
• MalfunctionAug 1, 2025Smoking; Smoking

  IT WAS REPORTED THAT THE PATIENT'S AT HOME DEVICE SUDDENLY STARTED GIVING OUT BLACK SMOKE AT HOME WHEN THE FLOW SETTING WAS AT 3 OR 4. DEVICE ALARM MESSAGES WERE SEEN AFTER THE SMOKE WAS RELEASED. PATIENT HAD A PORTABLE OXYGEN CONCENTRATOR DURING THE EVENT. THE AT HOME UNIT WAS REPLACED AND THE PATIENT IS DOING GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690635 ↗
• MalfunctionJul 17, 2025Smoking; Smoking

  IT WAS REPORTED THAT SMOKE STARTED COMING OUT OF THE PATIENT'S UNIT'S FILTER VENT AND WALL OUTLET DURING A STORM THAT CAUSED THEIR POWER LINE TO FALL DOWN. IT WAS NOTED THAT THE PATIENT'S DEVICE HAD STOPPED WORKING AFTER THAT. THE PATIENT USED THEIR PORTABLE OXYGEN TANK UNTIL A REPLACEMENT WAS RECEIVED. THE PATIENT IS DOING FINE WITH THEIR REPLACEMENT DEVICE. THE PATIENT WAS NOT HOSPITALIZED OR INJURED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535934 ↗
• InjuryJun 24, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON(B)(6) 2025, THE PATIENT CALLED INOGEN TO REPORT THAT SHE COULD NOT PULL THE OLD COLUMNS OUT TO REPLACE THEM ON THE (GS), AND THAT SHE HAD BEEN HOSPITALIZE DUE TO HER OXYGEN LEVELS DROPPING. THE PATIENT CONFIRMED RECEIVING OXYGEN AT THE HOSPITAL AND IS CURRENTLY BACK HOME RECOVERING.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Dyspnea

  MAUDE report 22320549 ↗
• MalfunctionJun 17, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2025, THE PATIENT CONTACTED INOGEN, TO REPORT THAT AN ERROR MESSAGE INDICATING A POTENTIAL FIRE HAZARD APPEARED ON THEIR GS HOME CONCENTRATOR. THE PATIENT DID NOT PROVIDE SPECIFIC DETAILS REGARDING THE CIRCUMSTANCES OF THE MESSAGE, INCLUDING WHEN OR HOW IT OCCURRED. INOGEN, ATTEMPTED TO FOLLOW UP WITH THE PATIENT ON THREE SEPARATE OCCASIONS TO GATHER MORE INFORMATION, BUT THE PATIENT WAS UNREACHABLE. NO INJURIES, FIRES, OR PROPERTY DAMAGE WERE REPORTED. THIS COMPLAINT IS BEING SUBMITTED DUE TO THE NATURE OF THE ERROR MESSAGE REFERENCING A POTENTIAL FIRE HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22243197 ↗