Inogen One G4 Oxygen Concentrator 630Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00817131020117), received between May 13, 2020 and Aug 28, 2026 — classified as 14 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (6 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Insufficient Flow or Under Infusion

  Patient problems: Dyspnea

  MAUDE report 50507468 ↗
• InjuryAug 26, 2026Insufficient Flow or Under Infusion; Unexpected Shutdown

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 50463931 ↗
• InjuryAug 3, 2026Insufficient Flow or Under Infusion

  Patient problems: Dyspnea; High Blood Pressure/ Hypertension

  MAUDE report 50116788 ↗
• InjuryJul 15, 2026Insufficient Flow or Under Infusion; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE OXYGEN DELIVERY ERROR MESSAGE, WAS NOISY, AND WAS NOT GIVING ENOUGH OXYGEN. IT WAS NOTED THAT THE PATIENT HAD A HEART ATTACK DUE TO THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Myocardial Infarction

  MAUDE report 25830430 ↗
• InjuryJun 12, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED TAT THE PATIENT'S DEVICE WAS SHOWING THE SYSTEM ERROR. AS A RESULT, THE PATIENT WAS EXPERIENCING DIFFICULTY BREATHING. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS THE PATIENT DECLINED FURTHER FOLLOW-UP

  Patient problems: Dyspnea

  MAUDE report 25486654 ↗
• InjuryNov 26, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT HAD BECOME HOSPITALIZED. HOWEVER, THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF EVENT TO ATTRIBUTE THE ADVERSE EVENT BEING RELATED TO THE DEVICE. ONCE THE PRODUCT WAS RETURNED AND INVESTIGATED, IT WAS DISCOVERED THAT THERE WAS AN OXYGEN ISSUE. FURTHER REVIEW OF THE INITIAL CALL REVEALED THAT PATIENT HAD CALLED FROM THE HOSPITAL STATING THAT THE UNIT HAD STOPPED PRODUCING OXYGEN EVEN AFTER REPLACING THE COLUMNS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23659284 ↗
• InjuryNov 19, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025 THE PATIENT CALLED INOGEN TO REPORT THAT HE WAS HAVING LOW OXYGEN ERROR. THE PATIENT CONFIRMED THE ISSUES WITH HIS OXYGEN G4 UNIT WHILE TRAVELING, RESULTING IN HOSPITALIZATION FOR 3 DAYS AFTER BEING OUT OF OXYGEN FOR 2 DAYS DURING A CRUISE. PER THE PATIENT HE IS BACK HOME RECOVERING, HE RECEIVED NEW COLUMNS FOR THE DEVICE WHICH IT IS NOW FUNCTIONING WELL WITH NO ISSUES.

  Patient problems: Dyspnea

  MAUDE report 23596779 ↗
• InjuryNov 19, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025 THE PATIENT CALLED INOGEN TO REPORT THE BATTERIES ON THE G4 DEVICE WERE NOT HOLDING CHARGE. THE PATIENT CLAIMED THAT DUE TO THE OXYGEN CUTTING OFF SUDDENLY ON HER DEVICE SHE HAD TO GO TO THE HOSPITAL DUE TO THAT. INOGEN, ATTEMPTED TO FOLLOW UP WITH THE PATIENT ON THREE SEPARATE OCCASIONS TO CONFIRM AND GATHER MORE INFORMATION ABOUT THE INCIDENT, BUT THE PATIENT WAS UNREACHABLE. THIS COMPLAINT IS BEING SUBMITTED DUE TO THE NATURE THE PATIENT CLAIMING SHE HAD TO GO TO THE HOSPITAL. INTERVENTION IS UNKNOWN.

  Patient problems: Dyspnea

  MAUDE report 23596223 ↗
• InjuryNov 12, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD STOPPED PROVIDING OXYGEN. NO ALARMS WERE NOTED. AS A RESULT, THE PATIENT HAD A GRAND MAL SEIZURE DUE TO THE LACK OF OXYGEN AND WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT DOES HAVE A SEIZURE DIAGNOSIS PRIOR TO THE EVENT AND IS ON MEDICATION. PATIENT HAD AN ALTERNATIVE OXYGEN SUPPLY SOURCE AT THE TIME OF THE EVENT, BUT WAS TRANSFERRED TO THE HOSPITAL OXYGEN SUPPLY WHEN ARRIVING TO THE HOSPITAL. PATIENT NOTED THAT THE SEIZURES LASTED APPROXIMATELY THREE TO FOUR MINUTES IN DURATION. PATIENT'S PULMONOLOGIST AGREED THAT THE EVENT WAS CAUSED DUE TO THE LACK OF OXYGEN. PATIENT RECEIVED A REPLACEMENT DEVICE AND IS DOING FINE.

  Patient problems: Convulsion/Seizure; Low Oxygen Saturation

  MAUDE report 23537562 ↗
• InjuryJul 31, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO LOW OXYGEN FROM THEIR DEVICE. THE PATIENT HAS EMPHYSEMA AND THE ISSUE INITIALLY OCCURRED AT THE PATIENT'S HOME. PATIENT STATED THEY HAD A STATIONARY OXYGEN CONCENTRATOR AS A BACKUP. PATIENT RECEIVED THEIR REPLACEMENT DEVICE AND IS DOING FINE. THE INOGEN TEAM ATTEMPTED TO INQUIRE FOR ADDITIONAL INFORMATION BUT THE PATIENT DECLINED.

  Patient problems: Dyspnea

  MAUDE report 22681137 ↗
• InjuryJul 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025 THE PATIENT CALLED INOGEN TO REPORT THAT SMOKE WAS COMING OUT OF THE THEIR G4 DEVICE. PATIENT STATED THEY TRIED TO CHARGE IT AGAIN BUT BURNING SMELL KEPT COMING OUT OF THE DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THIS REPORT IS BEING SUBMITTED DUE TO THE NATURE OF THE PATIENT CLAIMING THE DEVICE CHARGING PORT WAS SCORCHED.

  Patient problems: Dyspnea

  MAUDE report 22669503 ↗
• InjuryJul 16, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SYSTEM ERROR MESSAGE AND THE DEVICE WAS NOT GIVING ENOUGH OXYGEN. IT WAS NOTED THAT THE PATIENT HAD JUST GOT OUT OF THE HOSPITAL. IT IS UNCONFIRMED IF THE HOSPITALIZATION WAS DUE TO THE LOW OXYGEN. THE PATIENT WAS SENT A REPLACEMENT UNIT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 22526808 ↗
• InjuryJul 2, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  ON (B)(6) 2025 PATIENT'S DAUGHTER CALLED INOGEN TO REPORT THAT THE PATIENT'S DEVICE ROVE4 WAS NOT DELIVERING OXYGEN TO THE PATIENT. PER THE DAUGHTER SHE STATED PATIENT WAS IN DISTREES AND SHE HAD TO TAKE THE PATIENT TO THE HOSPITAL TO RECEIVE OXYGEN. THE PATIENT RECIEVED OXYGEN, THE DAUGHTER STATED SHE WAS CURRENTLY IN A REHAB RECOVERING.

  Patient problems: Dyspnea

  MAUDE report 22385338 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT REPORTED AN INABILITY TO TOLERATE THE ODOR EMITTED BY THE ASSEMBLY, CONCENTRATOR, G4 DEVICE, DESCRIBING IT AS HAVING A BURNING OR TOXIC SMELL. DURING AN OUTING, SHE ACTIVATED THE MACHINE BUT WAS UNABLE TO USE IT DUE TO THE ODOR. THIS CAUSED HER TO EXPERIENCE SHORTNESS OF BREATH AND A SENSE OF SUFFOCATION. THE DEVICE DID NOT EMIT ANY AUDIBLE OR VISUAL ALARMS DURING THE INCIDENT, AND SHE HAD AN ALTERNATIVE OXYGEN SUPPLY AVAILABLE. UPON FOLLOW-UP, THE PATIENT CONFIRMED THAT SHE DID NOT NEED HOSPITALIZATION AND EXPERIENCED NO ADVERSE HEALTH EFFECTS. SHE IS CURRENTLY STABLE, ON CONTINUOUS OXYGEN THERAPY AT LEVEL 2, AND DOING WELL. A REPLACEMENT UNIT WAS DISPATCHED THE FOLLOWING DAY AND HAS BEEN RECEIVED BY THE PATIENT. ALL NECESSARY REPORTING SUBMISSIONS RELATED TO THE EVENT HAVE BEEN COMPLETED.

  Patient problems: Dyspnea

  MAUDE report 21688866 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT WAS ON A PLANE WHEN THEIR OXYGEN CONCENTRATOR UNIT OVERHEATED, CAUSING THE PATIENT TO BE WITHOUT OXYGEN FOR APPROXIMATELY 5 MINUTES. AS A RESULT, THE PATIENT EXPERIENCED DIFFICULTY BREATHING, PROMPTING THE PLANE TO DEPLANE THE PATIENT UPON LANDING. THE PATIENT WAS TRANSPORTED TO A HOSPITAL IN (B)(6) CO, WHERE THEY WERE ADMITTED FOR 4 DAYS. DURING THE HOSPITAL STAY, THE PATIENT RECEIVED BREATHING TREATMENTS, ANTIBIOTICS, INHALERS, AND OXYGEN THERAPY. THE PATIENT WAS DIAGNOSED WITH CO2 POISONING AND CONTINUES TO RECEIVE TREATMENT, WITH A FOLLOW-UP APPOINTMENT SCHEDULED.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21688679 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT REPORTED THAT HER ASSEMBLY, CONCENTRATOR, G4 BT UNIT WAS NOISY WHILE SHE WAS USING IT. SHE AWOKE DURING THE NIGHT FEELING UNWELL AND NOTED THAT THE UNIT WAS NOT FUNCTIONING, WITH HER BLOOD OXYGEN LEVEL READING AT 65%. WHEN SHE ATTEMPTED TO REACTIVATE THE UNIT, IT PRODUCED A SOUND SIMILAR TO WALKING ON GRAVEL, FAILED TO CONCENTRATE AIR, AND DID NOT CHARGE THE BATTERY. ALTHOUGH THE PATIENT TYPICALLY KEEPS THE ALARMS ACTIVATED AND IS RESPONSIVE TO THEM, NO ALARMS[?]AUDIBLE OR VISUAL[?]WERE TRIGGERED DURING THE INCIDENT. FOLLOWING THE EVENT, THE PATIENT CONFIRMED SHE DID NOT GO TO THE HOSPITAL DESPITE EXPERIENCING WEAKNESS, AS SHE LIVES ALONE. SHE CONTINUES ON 24-7 OXYGEN THERAPY AND HAD AN ALTERNATIVE OXYGEN SUPPLY AVAILABLE DURING THE DEVICE FAILURE. A REPLACEMENT UNIT WAS PROVIDED TO HER THE NEXT DAY, AND ALL NECESSARY REPORTING REQUIREMENTS HAVE BEEN ADDRESSED.

  Patient problems: Dyspnea

  MAUDE report 21688582 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  A PATIENT REPORTED THAT THE BATTERY OF THEIR G4 4-CELL DEVICE WAS LASTING ONLY 25 MINUTES WHEN FULLY CHARGED, LEADING TO CONCERNS ABOUT THE DEVICE'S FUNCTIONALITY, THE PATIENT WAS CONTACTED MULTIPLE TIMES. DURING THE THIRD CONTACT, THE PATIENT SHARED THAT AFTER ATTACHING THE UNIT, THE STRAP BROKE, AND WITHIN 20 MINUTES, THE BATTERY LOST POWER. BOTH AUDIBLE AND VISUAL ALARMS WERE ACTIVE AT THE TIME. SHE SWITCHED TO AN ALTERNATIVE OXYGEN SUPPLY BUT STILL EXPERIENCED SHORTNESS OF BREATH. AS A RESULT, SHE WENT TO THE HOSPITAL AND WAS ADMITTED FOR FOUR DAYS, RECEIVING TREATMENT WITH MEDICATIONS, BREATHING TREATMENTS, AND SUPPLEMENTAL OXYGEN. FOLLOWING HER DISCHARGE, THE PATIENT REPORTED THAT SHE WAS DOING FINE, THOUGH SHE CONTINUED TO EXPERIENCE SOME DIFFICULTY BREATHING DUE TO HER MEDICAL CONDITION. SHE REMAINS ON OXYGEN 24/7 AT LEVEL 5 AND DID NOT RECEIVE A REPLACEMENT UNIT. NO ONGOING COMPLICATIONS FROM THE EVENT WERE NOTED.

  Patient problems: Dyspnea

  MAUDE report 21688581 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT WAS HOSPITALIZED FOR SHORTNESS OF BREATH AND DID EXPERIENCE ANY ADVERSE HEALTH CONSEQUENCES BECAUSE OF THE EVENT. THE PATIENT REPORTED EXPERIENCING SHORTNESS OF BREATH. ATTEMPTS TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION WERE MADE THREE TIMES VIA PHONE AND EMAIL BUT WERE UNSUCCESSFUL. THE DETAILS OF HER HOSPITALIZATION ABOUT HOW THEY GOT THERE, THE LENGTH OF STAY, OR SPECIFICS OF THE HOSPITAL VISIT REMAIN UNCLEAR, AS WELL AS TREATMENT, MEDICATIONS, OR TESTING. IT IS UNKNOWN IF THE EVENT HAS BEEN RESOLVED, WHETHER THE PATIENT IS EXPERIENCING ANY ONGOING COMPLICATIONS, OR IF FOLLOW-UP IS NEEDED. DETAILS ABOUT THE PATIENT'S PRESCRIBED OXYGEN USAGE, DEVICE SETTINGS, AND WHETHER ANY ALARMS WERE ACTIVE DURING THE INCIDENT HAVE NOT BEEN CONFIRMED. IT'S ALSO UNCLEAR IF AN ALTERNATIVE OXYGEN SUPPLY WAS AVAILABLE OR IF A REPLACEMENT UNIT HAS BEEN RECEIVED.

  Patient problems: Dyspnea

  MAUDE report 21688568 ↗
• MalfunctionMar 25, 2025Output Problem; Output Problem

  THE PATIENT STATED EXPERIENCING A DEVICE ISSUE WHERE NO OXYGEN WAS BEING RELEASED FROM HER UNIT. THIS LED TO SEVERE SHORTNESS OF BREATH AND AN OXYGEN SATURATION LEVEL OF 75%. EMERGENCY SERVICES WERE CONTACTED, AND THE PATIENT WAS HOSPITALIZED. AFTER EVALUATION, SHE WAS ADMITTED FOR FIVE DAYS. DURING HER STAY, SHE RECEIVED OXYGEN THERAPY AND MEDICATIONS. THE REPORTED ISSUE WAS ATTRIBUTED TO THE G4 UNIT, WHICH WAS REPLACED FOLLOWING A TROUBLESHOOTING ATTEMPT INVOLVING A HARD RESET, THOUGH THE PROBLEM PERSISTED. THE PATIENT'S DAUGHTER PROVIDED ADDITIONAL DETAILS. THE PATIENT USES OXYGEN 24/7 AT A SETTING OF 3 DUE TO COPD. DURING THE EVENT, THE DEVICE EMITTED AN AUDIBLE ALARM. DESPITE HAVING A HOUSE UNIT AS AN ALTERNATIVE SUPPLY, THE LACK OF OXYGEN FROM THE PORTABLE DEVICE NECESSITATED EMERGENCY INTERVENTION.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 21688217 ↗
• MalfunctionFeb 25, 2025No Flow; No Flow

  ACCORDING TO THE PATIENT, HE WAS ON A BUS TOUR WHEN THE UNIT STOPPED WORKING. HE REPORTED FEELING SICK AND OUT OF BREATH SO HE WAS TAKEN TO THE NEAREST HOSPITAL. AT THE HOSPITAL HE WAS GIVEN OXYGEN AND MEDICINE. HE STATED THAT THE UNIT DISPLAYED A SYSTEM ERROR AND STOPPED WORKING. THE PATIENT HAS A HISTORY OF COPD. HE ALSO REPORTED THAT HE RECEIVED A REPLACEMENT UNIT.

  Patient problems: Hypoxia

  MAUDE report 21464049 ↗
• MalfunctionNov 11, 2024No Flow; No Flow

  ACCORDING TO THE PATIENT, SHE WAS SHOPPING WHILE HER DEVICE STOP WORKING. SHE SAID THAT SHE COULD NOT BREATH. SHE CLAIMS THAT THEY CALLED 911 AND TRANSPORTED HER TO THE HOSPITAL. SHE REPORTED THAT THE HOSPITAL STAFF GAVE HER OXYGEN, BREATHING TREATMENT AND SENT HER HOME THAT SAME DAY. SHE STATED THAT HER AID BROUGHT HER ANOTHER DEVICE SO SHE CAN GO HOME. SHE SAID THAT SHE HAD A HOME UNIT AND ANOTHER DEVICE AT HOME. THE PATIENT HAS RECEIVED A REPLACEMENT UNIT. THE PATIENT HAS A HISTORY OF LUNG CANCER.

  Patient problems: Hypoxia

  MAUDE report 20657973 ↗
• MalfunctionJul 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE PATIENT, THE DEVICE WAS NOT ADMINISTERING CONSISTENT BOLUS. SOMETIMES THE BOLUS WOULD BE STRONG AND OTHER TIMES IT WOULD BE WEAK. THE PATIENT FELT THAT THEY WEREN'T GETTING ENOUGH AIR AND WOULD GET SHORT OF BREATH AND WOULD GO TO ROOM WITH THE AT HOME UNIT.

  Patient problems: Insufficient Information; Unspecified Respiratory Problem

  MAUDE report 19732009 ↗
• MalfunctionMay 7, 2021No Audible Alarm; Adverse Event Without Identified Device or Use Problem; No Audible Alarm; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REVEALED THE ADVERSE EVENT WAS UNRELATED TO THE INOGEN DEVICE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11792594 ↗
• MalfunctionJul 24, 2020Circuit Failure; Overheating of Device; Circuit Failure; Overheating of Device

  IT WAS ALLEGEDLY REPORTED BY THE PATIENT THAT THEIR G4 BATTERY WOULD NOT TAKE A CHARGE AND THAT THE UNIT WAS GETTING HOT. THE PATIENT SWAPPED OUT THE BATTERY AND USED THE UNIT IN THE CAR THE FOLLOWING DAY WHILE ON THE WAY TO HER DOCTOR'S OFFICE. IT WAS REPORTED THAT, WHEN THE UNIT WAS TURNED ON, IT ALLEGEDLY BEGAN SMOKING. ONCE SHE ARRIVED AT THE DOCTOR'S OFFICE, SHE WAS PROVIDED WITH OXYGEN AND A WHEELCHAIR.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10319775 ↗
• InjuryMay 13, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE PATIENT THAT, WHILE RIDING IN THE CAR, SHE STARTED TO FEEL ILL AND HER O2 LEVELS ALLEGEDLY DROPPED. WHEN THIS OCCURRED, HER HUSBAND DROVE HER TO THE HOSPITAL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10053506 ↗

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