Inogen Rove 6 10-12017-00-02 (BT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00817131020513), received between Jun 28, 2024 and Sep 29, 2026 — classified as 1 death, 26 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (14 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 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Failure to Run on Battery; No Flow

  It was reported that the patient's unit stopped working following a routine battery change. As a result, the patient's oxygen levels started to drop and they experienced shortness of breath. They were able to make it back home and use their stationary concentrator without further intervention. A replacement unit was sent to the patient and it is working for them.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50927274 ↗
• InjurySep 15, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's unit showed a low oxygen error message and did not produce enough oxygen while the patient was walking. As a result, the patient's oxygen levels dropped. The patient stated they would call back for additional troubleshooting at a later date.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50766701 ↗
• InjurySep 13, 2026Insufficient Flow or Under Infusion; Unexpected Shutdown

  Patient problems: Low Oxygen Saturation

  MAUDE report 50747818 ↗
• InjurySep 2, 2026Insufficient Flow or Under Infusion; Unexpected Shutdown

  Patient problems: Syncope/Fainting

  MAUDE report 50569724 ↗
• InjuryAug 27, 2026Premature Discharge of Battery; Overheating of Device; Unexpected Shutdown

  It was reported that the patient's device was shutting off by itself and the battery was not lasting when they were outside of their home. The System Hot error message was seen. As a result, the patient's oxygen levels decreased and they were taken to the hospital. No additional information is available at this time as multiple attempts to contact the patient were unsuccessful.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50486321 ↗
• InjuryAug 14, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50262370 ↗
• InjuryAug 14, 2026Failure to Deliver

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 50260404 ↗
• MalfunctionAug 13, 2026Electrical /Electronic Property Problem; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240786 ↗
• MalfunctionAug 12, 2026Fire

  It was reported that the patient's device charger burned and damaged the device while it was being charged. A burning smell was observed due to the event. It was noted that there was minor property damage, but there were no reported injuries or negative impact to patient's health due to the event. This report will be on the patient's device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229606 ↗
• InjuryAug 11, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's device was displaying the system error message in their car. 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 50216754 ↗
• InjuryAug 5, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's device was displaying the low oxygen error message. As a result, the patient stated they could not breathe and were hospitalized. 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 50149873 ↗
• InjuryAug 5, 2026Insufficient Flow or Under Infusion

  Patient problems: Low Oxygen Saturation

  MAUDE report 50143833 ↗
• InjuryJul 30, 2026Battery Problem; Unexpected Shutdown

  It was reported that the patient's device was shutting off by itself more frequently while they were out. It was noted that the Check Battery error message was seen. The patient does have have a backup oxygen tank, but did not have it with them at the time of the event. As a result, the patient started experiencing shortness of breath and an ambulance was called. The patient was taken to the hospital where they were admitted for 3 weeks. The patient has since been released from the hospital and has no ongoing complications due to the event.

  Patient problems: Dyspnea

  MAUDE report 50092456 ↗
• InjuryJul 27, 2026Insufficient Flow or Under Infusion

  It was reported that the patient was having issues with their device. As a result, their oxygen levels had decreased. The patient did not have a backup device at the time of the event. The patient was hospitalized for 3 weeks and had 3 weeks of rehab. The patient has received their replacement device and does not have any ongoing complications due to the event.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50045243 ↗
• InjuryJul 8, 2026Overheating of Device; No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD AN ERROR MESSAGE AND WAS OVERHEATING CAUSING A LOUD NOISE. IN TURN, THE UNIT SUDDENLY SHUTDOWN LEADING TO NO OXYGEN CAUSING THE PATIENT TO HAVE SHORTNESS OF BREATH. THIS HAPPENED WHILE THEY WERE IN A CAR AND THEY HAD TO GO BACK HOME, WHERE THEY WERE ABLE TO USE THEIR STATIONARY CONCENTRATOR TO GET OXYGEN AGAIN. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM.

  Patient problems: Dyspnea

  MAUDE report 25748635 ↗
• InjuryJul 1, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT DISPLAYED AN ERROR MESSAGE AND TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. AS A RESULT, THE UNIT WAS NOT PRODUCING ENOUGH OXYGEN AND IT CAUSED THE PATIENT TO HAVE SHORTNESS OF BREATH AND LOW OXYGEN. THE PATIENT MADE IT BACK HOME WHERE THEY WERE ABLE TO USE THEIR STATIONARY CONCENTRATOR WITHOUT FURTHER INTERVENTION. A REPLACEMENT UNIT WAS SENT TO THE PATIENT.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 25678352 ↗
• InjuryMay 19, 2026Battery Problem; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE BATTERY ERROR MESSAGE AND THE FAN WAS NOISIER WHILE THE PATIENT WAS AT WORK. IT WAS NOTED THAT THE PATIENT'S OXYGEN LEVELS HAD DROPPED BELOW 75% AND EXPERIENCED DIFFICULTY BREATHING DUE TO THE EVENT. AS A RESULT, THE PATIENT WENT BACK HOME TO THEIR STATIONARY OXYGEN CONCENTRATOR AND THEY LATER REPLACED THEIR DEVICE. PATIENT HAS NO ONGOING ISSUES DUE TO THE EVENT.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 25222377 ↗
• InjuryApr 16, 2026No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE UNIT SHUTS DOWN BY ITSELF. AS A RESULT, THE PATIENT WAS NOT RECEIVING OXYGEN AND HAD TO DIAL EMERGENCY SERVICES. 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: Low Oxygen Saturation

  MAUDE report 24900116 ↗
• InjuryApr 6, 2026Premature Discharge of Battery; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT WAS HAVING POWER ISSUES WITH THEIR UNIT AND THEY WERE NOT GETTING ENOUGH OXYGEN AS A CONSEQUENCE. AS A RESULT, THE PATIENT HAD SHORTNESS OF BREATH AND HAD TO BE HOSPITALIZED. THEY WERE DISCHARGED AFTER 3 DAYS. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING WELL FOR THEM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24794525 ↗
• InjuryMar 31, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE DEVICE WAS NOT GIVING THE PATIENT ENOUGH OXYGEN WHILE GOING ON A WALK. THE SYSTEM ERROR MESSAGE WAS SEEN. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED AND THE PATIENT ALMOST FAINTED, GOING DOWN ON THEIR KNEES. PATIENT THEN WENT BACK HOME AND GOT BACK ON THEIR STATIONARY DEVICE WHERE THEY STABILIZED. PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT DEVICE AND IS DOING FINE.

  Patient problems: Low Oxygen Saturation; Presyncope

  MAUDE report 24748014 ↗
• InjuryMar 26, 2026No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S UNIT STOPPED WORKING AND WAS NOT OUTPUTTING OXYGEN. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED AND THEY HAD TO GO TO THE EMERGENCY ROOM. THEY WERE DISCHARGED THE NEXT DAY AND TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. 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: Low Oxygen Saturation

  MAUDE report 24706726 ↗
• InjuryMar 19, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT PRODUCING ENOUGH OXYGEN DURING THEIR MOTHER'S FUNERAL. THE DEVICE DISPLAYED AN ERROR CODE AND THE PATIENT STATED THEY WERE HAVING DIFFICULTY BREATHING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Dyspnea

  MAUDE report 24639818 ↗
• InjuryMar 18, 2026No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE UNIT STARTED ACTING UP FOLLOWING A ROUTINE COLUMN REPLACEMENT. WHILE TROUBLESHOOTING, THE UNIT SHUT DOWN AND WOULD NOT TURN BACK ON. AS A RESULT, THE PATIENT COULD NOT BREATHE. 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 24630852 ↗
• InjuryJan 26, 2026Smoking; No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT STARTED SMELLING LIKE IT WAS BURNING. THE PATIENT'S SON ALSO REPORTED THAT THE PATIENT HAD SHORTNESS OF BREATH AND THEY WERE NOT GETTING OXYGEN WHEN THE NOTICED THE BURNING SMELL. THEY NOTICED THAT THE UNIT HAD SMOKE COMING OUT OF THE BACK OF THE UNIT. THEY DID NOT HAVE GO TO THE HOSPITAL, BUT THEY DID HAVE A SMALL TANK OF OXYGEN WITH THEM IN THE TRUCK. THEY WERE HOUSE BOUND WITH THEIR STATIONARY UNIT UNTIL THEY RECEIVED THE REPLACEMENT PORTABLE ONE WHICH IS WORKING WELL FOR THEM AT THIS TIME.

  Patient problems: Dyspnea; Respiratory Insufficiency

  MAUDE report 24184742 ↗
• InjuryOct 24, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT GIVING OUT OXYGEN. AS A RESULT, THE PATIENT WAS HOSPITALIZED. IT WAS NOTED HOWEVER THAT THE PATIENT DID HAVE AN OXYGEN TANK AS A BACKUP AT THE TIME. THE PATIENT WAS GIVEN A REPLACEMENT AND THE PATIENT IS NOW DOING BETTER.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23382272 ↗