Inogen One G4 Oxygen Concentrator - Bluetooth 630 BluetoothRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00817131020179), received between Aug 28, 2019 and Sep 29, 2026 — classified as 1 death, 36 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (13 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 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Overheating of Device; No Flow; Unexpected Shutdown

  It was reported that the patient's unit was overheating and had shutdown while they were out at a grocery store. As a result, the patient experienced difficulty breathing and had an episode. The patient's daughter was able to provide them supplemental oxygen with a spare tank and the patient stabilized without further intervention. The patient's unit was replaced following additional troubleshooting at a later date, however there were no patient issues reported at that time. The replacement unit was received and it is working for them.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50927490 ↗
• InjurySep 24, 2026Overheating of Device; Insufficient Flow or Under Infusion

  Patient problems: Dyspnea

  MAUDE report 50892127 ↗
• InjurySep 23, 2026Unexpected Shutdown

  It was reported that the patient's unit had a replace columns message and then stopped working. As a result, the patient had difficulty breathing, but they were able to make it back home to their stationary concentrator without further intervention. Troubleshooting did not resolve the issue and replacement columns were sent to the patient. The patient received the replacement columns and were able to resume their therapy with the unit. While the issue is with the columns, the patient's unit will be the reported device for this report.

  Patient problems: Dyspnea

  MAUDE report 50873002 ↗
• InjurySep 23, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50872315 ↗
• InjurySep 22, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's device was displaying the low oxygen error message despite having their columns replaced. As a result, the patient would start coughing after 30 minutes of using the device. Replacement columns were sent to the patient. Although this event is on the device columns, this report will be on the actual device. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Cough

  MAUDE report 50857455 ↗
• InjurySep 18, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50829258 ↗
• InjurySep 18, 2026Failure to Deliver

  Patient problems: Low Oxygen Saturation

  MAUDE report 50824742 ↗
• InjurySep 1, 2026Overheating of Device; Unexpected Shutdown

  It was reported that the patient's device was getting hot and shutting off while going to the doctor. As a result, the patient experienced shortness of breath. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Dyspnea

  MAUDE report 50547752 ↗
• InjuryJul 28, 2026Unexpected Shutdown

  It was reported that the patient's unit shuts down after a few seconds of being switched on. Troubleshooting did not resolve the issue. As a result, the patient stated that they had ambulatory issues without the use of their portable oxygen concentrator, however they were not hospitalized due to this. The Inogen Team attempted to contact the patient for further information three times with no response.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 50055247 ↗
• InjuryJul 27, 2026Unexpected Shutdown

  It was reported that the patient's device was shutting off when the patient was in their doctor's office. The System Error message was noted on the device. As a result, the patient was feeling dizzy and light headed. A replacement device was sent to the patient.

  Patient problems: Dizziness

  MAUDE report 50040889 ↗
• InjuryJul 6, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS NOT PRODUCING ENOUGH OXYGEN AND IT WAS NOISY. AS A RESULT, THE PATIENT'S OXYGEN LEVELS HAD DROPPED. REPLACEMENT COLUMNS WERE SENT TO THE PATIENT TO RESOLVE THE ISSUE. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25726619 ↗
• InjuryJun 15, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD A LOW OXYGEN ERROR MESSAGE AND WAS NOT PRODUCING ENOUGH OXYGEN FOR THE PATIENT FOLLOWING A COLUMN REPLACEMENT. AS A RESULT, THE PATIENT HAD TO GO TO THE ER AND ADMITTED TO THE HOSPITAL. IT WAS ALSO STATED THAT THE PATIENT MAY HAVE BEEN USING THE UNIT IMPROPERLY WITHOUT COLUMNS LEADING TO THE HOSPITALIZATION. THIS WILL STILL BE REPORTED AS AN ADVERSE EVENT OUT OF AN ABUNDANCE OF CAUTION AS THE PATIENT'S OXYGEN NEEDS MAY HAVE CHANGED OVER TIME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25513024 ↗
• InjuryJun 9, 2026Overheating of Device; Insufficient Flow or Under Infusion; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOISY, OVERHEATING, AND NOT PROVIDING ENOUGH OXYGEN. REPLACEMENT COLUMNS DID NOT RESOLVE THE ISSUE. AS A RESULT, THE PATIENT'S OXYGEN LEVELS WOULD DROP AND THEY WOULD EXPERIENCE DIFFICULTY BREATHING. WHEN THE PATIENT IS HOME, THEY ARE ABLE TO GO TO THEIR STATIONARY UNIT; HOWEVER, WHEN THE PATIENT IS AT WORK TRAVELING, THEY ARE UNABLE TO GET ACCESS TO A BACKUP DEVICE. THE PATIENT MENTIONED THEY HAVE BEEN HOSPITALIZED PREVIOUSLY DUE TO THIS ISSUE. A REPLACEMENT DEVICE WAS SENT OUT TO THE PATIENT AND THE PATIENT IS DOING BETTER.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 25446325 ↗
• InjuryJun 9, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS NOT PRODUCING ENOUGH OXYGEN WHILE THEY WERE FLYING. AS A RESULT, THE PATIENT'S OXYGEN DROPPED TO BELOW 80%. THEY WERE PROVIDED SUPPLEMENTAL OXYGEN ON THE AIRPLANE UNTIL THE ALTITUDE CHANGED AND THEY WERE ABLE TO USE THE UNIT ONCE AGAIN. A REPLACEMENT DEVICE WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM. THE EVENT DID NOT LEAD TO HOSPITALIZATION.

  Patient problems: Dizziness; Low Oxygen Saturation

  MAUDE report 25444553 ↗
• InjuryApr 23, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS PERSISTENTLY DISPLAYING THE SYSTEM ERROR MESSAGE AND WAS NOT PROVIDING ENOUGH OXYGEN. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING A HEADACHE DUE TO THE EVENT. AS A RESULT, THE PATIENT WENT TO THE DOCTOR WHERE THEY WERE GIVEN OXYGEN. PATIENT THEN WENT HOME TO THEIR STATIONARY DEVICE AND WAS STABLE. PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT DEVICE AND IS DOING BETTER.

  Patient problems: Headache; Low Oxygen Saturation

  MAUDE report 24968807 ↗
• InjuryApr 23, 2026Overheating of Device; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT OPERATING PROPERLY AND THE CANNULA BARB HAD BROKEN WHILE AT CHURCH. THE SYSTEM HOT MESSAGE WAS NOTED. AS A RESULT, THE PATIENT WENT TO THE HOSPITAL DUE TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24967799 ↗
• InjuryApr 21, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT PRODUCING OXYGEN AND A SYSTEM HOT MESSAGE WAS SEEN. AS A RESULT, THE PATIENT STARTED EXPERIENCING SHORTNESS OF BREATH AND THEIR OXYGEN LEVELS HAD DROPPED. THE PATIENT WAS SENT TO THE HOSPITALIZED AND WAS ADMITTED FOR FOUR DAYS. THE PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT DEVICE AND IS DOING FINE.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 24945426 ↗
• InjuryApr 17, 2026Complete Loss of Power

  IT WAS REPORTED THAT WHEN THE PATIENT WAS OUTSIDE, THE PATIENT'S DEVICE WAS NOT WORKING AS IT WAS NOT POWERING ON WITH A BATTERY. PATIENT STATED THAT THEY HAD A HEART ATTACK DUE TO THE EVENT AND WAS HOSPITALIZED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Angina

  MAUDE report 24916685 ↗
• InjuryApr 17, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD A SYSTEM ERROR AND WAS NOT OUTPUTTING OXYGEN. TROUBLESHOOTING DID RESOLVE THE ISSUE. AS A RESULT, THE PATIENT WAS OUT OF BREATH AND A HARD TIME BREATHING. 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 24913031 ↗
• InjuryApr 17, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT RECOGNIZING THE BATTERY WHEN THEY WERE OUT SHOPPING. AS A RESULT, THE PATIENT EXPERIENCED DIFFICULTY BREATHING. 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 24912649 ↗
• InjuryApr 13, 2026No Flow; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S UNIT STARTED MAKING LOUD MOTOR NOISES FOLLOWING THE DEVICE BEING DROPPED. AS A RESULT, THE PATIENT WAS STRUGGLING TO BREATHE AS THE UNIT WAS NOT FUNCTIONAL. 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 24866597 ↗
• InjuryApr 13, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE UNIT WAS OUTPUTTING LOW OXYGEN FOLLOWING A COLUMN REPLACEMENT. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. AS A RESULT, THE PATIENT HAD DIFFICULTY BREATHING. A REPLACEMENT DEVICE 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 24865737 ↗
• InjuryApr 8, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS SHOWING A COLUMN ERROR MESSAGE AND WAS NOT PRODUCING OXYGEN. AS A RESULT, THE PATIENT PASSED OUT DUE TO LACK OF OXYGEN AND HAD TO BE TAKEN TO THE ER WHERE THEY WERE KEPT OVERNIGHT AND GIVEN SUPPLEMENTAL OXYGEN. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 24816971 ↗
• InjuryApr 6, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD A LOW OXYGEN ERROR MESSAGE. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND AS A RESULT, THE PATIENT HAD DIFFICULTY BREATHING. IT WAS ALSO REPORTED THAT UNIT WAS NOT PRODUCING ANY OXYGEN AT THE TIME OF THE EVENT. SUBSEQUENTLY, A FEW DAYS LATER, THE PATIENT HAD A COPD FLARE-UP AND HAD TO BE HOSPITALIZED. IT IS UNCLEAR IF THE UNIT WAS THE DIRECT CAUSE, BUT THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT WAS MOVED FROM THE HOSPITAL TO A REHAB FACILITY. THE REPLACEMENT UNIT WAS RECEIVED AND IT IS WORKING WELL FOR THEM.

  Patient problems: Dyspnea

  MAUDE report 24794673 ↗
• InjuryMar 25, 2026Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOISY AND THE SYSTEM HOT ERROR MESSAGE WAS SEEN. IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVELS DROPPED TO 67%. TROUBLESHOOTING WAS PERFORMED. STILL, THE DEVICE WAS REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24692005 ↗

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