Inogen One G3 Oxygen Concentrator 840 (REF IO-300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00817131020049), received between May 27, 2021 and May 29, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE REPLACE COLUMNS MESSAGE. AS A RESULT, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND THEIR OXYGEN LEVELS DECREASED WHILE AT HOME. PATIENT DID HAVE A STATIONARY UNIT AT THE TIME OF THE EVENT, BUT WAS BROUGHT TO THE EMERGENCY ROOM TWICE DUE TO THIS EVENT. PATIENT WAS ONLY THERE FOR A COUPLE OF HOURS ON BOTH OCCASIONS. REPLACEMENT COLUMNS HAVE BEEN SHIPPED OUT TO THE PATIENT.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 25333148 ↗
• InjuryApr 16, 2026Complete Loss of Power

  IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD NO POWER WHILE THEY WERE OUT. AS A RESULT, THE PATIENT WAS SENT TO THE HOSPITAL. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT. PATIENT STATED THAT THEIR DEVICE IS WORKING FINE AND HAVE NO ISSUES.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24896736 ↗
• InjuryMar 19, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD STOPPED PRODUCING OXYGEN. AS A RESULT, THE PATIENT GOT HOSPITALIZED WHERE THEY WERE PROVIDED SUPPLEMENTAL OXYGEN. THEY WERE DISCHARGED AFTER ONE WEEK. A REPLACEMENT UNIT WAS SENT TO THEM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24644413 ↗
• InjuryFeb 5, 2026Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO POWER ON OR OFF THEIR DEVICE WHILE RUNNING. TROUBLESHOOTING REVEALED AN ERROR MESSAGE. AS A RESULT, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO THEIR OXYGEN LEVELS DECLINING. NO FURTHER INFORMATION IS AVAILABLE. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24273434 ↗
• InjuryDec 16, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD OVERHEATED AND RECEIVED THE REPLACE COLUMNS MESSAGE WHEN THEY WERE LEAVING CHURCH. THE PATIENT HAPPENED TO BE IN FRONT OF THE ER AT THE TIME OF THE EVENT, SO THEY WENT AND STAYED THERE FOR A COUPLE OF HOURS UNTIL THEY WERE RELEASED TO THEIR HOME. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT, NO FURTHER INFORMATION IS AVAILABLE. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE. ALTHOUGH THIS ISSUE IS ATTRIBUTED TO THE DEVICE'S COLUMNS, THIS EVENT WILL BE REPORTED ON THE OXYGEN CONCENTRATOR UNIT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 23822498 ↗
• InjuryNov 26, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DAUGHTER STATED THE PATIENT WAS IN THE HOSPITAL DUE TO THE UNIT NOT WORKING. THEY STATED THAT THE PATIENT'S OXYGEN SATURATION DROPPED TO 89% AND BOUNCED BACK TO 90%. THE PATIENT'S DAUGHTER STATED THAT THE PATIENT WAS UNABLE TO GET ENOUGH OXYGEN FROM THE UNIT THEREFORE THEY WERE HOSPITALIZED. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23659479 ↗
• MalfunctionAug 13, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON JULY 18, 2025, THE PATIENT CONTACTED INOGEN, TO REPORT SMOKE AND GETTING BURN UPON PLUGGING IN THEIR G3 DEVICE. THE PATIENT DID NOT PROVIDE SPECIFIC DETAILS REGARDING THE CIRCUMSTANCES OF 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 FIRES, OR PROPERTY DAMAGE WERE REPORTED. INTERVENTION IS UNKNOWN. THIS COMPLAINT IS BEING SUBMITTED DUE TO THE NATURE OF PATIENT CLAIMING THEY HAD GOTTEN BURNT AND REFERENCING A POTENTIAL FIRE HAZARD.

  Patient problems: Dyspnea

  MAUDE report 22798410 ↗
• InjuryJun 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025, THE PATIENT'S DAUGHTER CALLED INOGEN, TO REPORT THAT HER CONCENTRATOR WAS NOT DISPENSING OXYGEN. PER THE DAUGHTER SHE STATED THE PATIENT WAS HOSPITALIZED DUE TO THE CONCENTRATOR NOT WORKING. INGOEN, TRIED TO REACH PATIENT ON THREE DIFFERENT OCCASIONS AND WAS UNSUCCESSFUL REACHING PATIENT TO GET FULL DETAILS ABOUT THE INCIDENT.

  Patient problems: Dyspnea

  MAUDE report 22360431 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  A UNIT WAS REPORTED TO BE DISPLAYING A TEMPERATURE ERROR, LEADING TO OPERATIONAL FAILURE. THE PATIENT'S MACHINE SHUT DOWN WHILE IN ROUTE TO A DOCTOR'S APPOINTMENT, AND UPON ARRIVAL AT THE DOCTOR'S OFFICE, THE UNIT WOULD NOT STAY ON. THE PATIENT, WHO IS PRESCRIBED 24/7 OXYGEN AT A SETTING OF 6, WAS UNABLE TO BREATHE INDEPENDENTLY. AS A RESULT, THE DOCTOR'S OFFICE CALLED AN AMBULANCE, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL, WHERE THEY REMAINED FOR SIX DAYS. THE PATIENT CONFIRMED EXPERIENCING ADVERSE HEALTH CONSEQUENCES DUE TO THE INCIDENT. DURING HOSPITALIZATION, THE PATIENT RECEIVED BREATHING TREATMENTS, SUPPLEMENTAL OXYGEN, AND ANTIBIOTICS. ADDITIONAL PATIENT DETAILS INDICATE PRE-EXISTING CONDITIONS, INCLUDING COPD, EMPHYSEMA, AND LUNG CANCER, WHICH MAY HAVE CONTRIBUTED TO THE SEVERITY OF THE HEALTH EVENT. THE PATIENT DID NOT OBSERVE ANY AUDIBLE OR VISUAL ALARMS ON THE DEVICE AT THE TIME OF THE INCIDENT OTHER THAN THE TEMPERATURE ERROR.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21688199 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  A ROUTINE SYSTEM ALERT HAD BEEN DISPLAYED[?] AN "O2 SERVICE SOON" MESSAGE[?] INDICATING THAT THE UNIT'S COLUMNS WERE OVER FOUR YEARS OLD. THE PATIENT STATED THAT THEY EXPERIENCED AN UNEXPECTED DIZZY SPELL, THE EPISODE LED TO A FALL WHILE USING THE PORTABLE OXYGEN CONCENTRATOR. THE IMPACT MAY HAVE TRIGGERED THE DEVICE'S ALERT, BUT THE SEQUENCE OF EVENTS REMAINED UNCERTAIN. THE PATIENT SUSTAINED A GASH ON HER HEAD, REQUIRING A VISIT TO THE HOSPITAL, WHERE SHE REMAINED FOR THE DAY. THE PATIENT DOES NOT BELIEVE THE DIZZINESS WAS CAUSED BY THE UNIT. THE DEVICE IN QUESTION WAS A G3 CONCENTRATOR. MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE MADE VIA PHONE AND EMAIL BUT WERE UNSUCCESSFUL.

  Patient problems: Dyspnea

  MAUDE report 21688185 ↗
• MalfunctionMar 5, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE UNIT GOT TOO WARM AND A SYSTEM HOT ERROR MESSAGE DISPLAYED ON THE UNIT. THE UNIT BURNED ON THE PATIENT'S STOMACH, THE CANNULA CAME OFF THE UNIT WHEN THEY TOOK OUT THE BATTERY, AND THE CUSTOMER CUT THEIR CHIN. IT WAS REPORTED THAT THE CUSTOMER DID NOT GO TO THE HOSPITAL FOR THESE INJURIES. THE INOGEN TEAM ATTEMPTED TO CONTACT PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE. INTERVENTION IS UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 21528000 ↗
• MalfunctionJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE PATIENT, THE INOGEN G3 PORTABLE OXYGEN CONCENTRATOR GOT SO HOT IT BURNED THE CUSTOMERS ARM.

  Patient problems: Burn(s)

  MAUDE report 19731752 ↗
• MalfunctionJan 11, 2024Gas Output Problem; Gas Output Problem

  THE CUSTOMER REPORTED TO INOGEN, THAT THE DEVICE DISPLAYED EXHAUST ERROR. THE DEVICE ALARMED DURING THE EVENT. REPORTEDLY, THE CUSTOMER SPENT OVERNIGHT IN THE HOSPITAL WHEREIN THE CUSTOMER RECEIVED ADDITIONAL OXYGEN. IN TURN, THE CUSTOMER RECEIVED A REPLACEMENT DEVICE AND IS FEELING BETTER.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18491743 ↗
• MalfunctionMay 27, 2021Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE PATIENT'S UNIT DISPLAYED AN ERROR MESSAGE "NO BREATH DETECTED." IN TURN THE PATIENT EXPERIENCED A LACK OF OXYGEN FROM THEIR UNIT. TROUBLESHOOTING WAS TRIED TO NO AVAIL. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11898641 ↗

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