Inogen Rove 4 10-10417-00-01 (BT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00817131020414), received between Jul 18, 2025 and Sep 25, 2026 — classified as 36 injuries.

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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Unexpected Shutdown

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50903687 ↗
• InjurySep 16, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's unit was displaying a replace columns message and it was not outputting enough oxygen. As a result, the patient had 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; Low Oxygen Saturation

  MAUDE report 50793977 ↗
• InjurySep 9, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's unit had a system error message. As a result, the unit was not producing enough oxygen resulting in shortness of breath. 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; Low Oxygen Saturation

  MAUDE report 50682359 ↗
• InjuryAug 31, 2026Premature Discharge of Battery

  It was reported that the patient's battery was not lasting as long with a full charge. As a result, the unit lost power and completely shut down causing the patient to have shortness of breath due to no oxygen from the unit. Troubleshooting did not resolve the issue, but it was determined that the battery needed to be replaced. A replacement battery was sent to the patient and it is working as intended for them. Because the battery is an accessory to the device, the unit is listed below, but the issue remains with the battery.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50531547 ↗
• InjuryAug 27, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's unit was not providing enough oxygen to the patient and the unit had a low oxygen error message. As a result, the patient had difficulty breathing and had to increase their flow settings to compensate. A replacement unit was sent to the patient and it is working for them.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 50484285 ↗
• InjuryAug 25, 2026Insufficient Flow or Under Infusion

  Patient problems: Dizziness

  MAUDE report 50441880 ↗
• InjuryAug 11, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's device was displaying the system error message and was not providing enough oxygen. As a result, the patient experienced shortness of breath. The patient did not have a backup at the time of the event. The patient has since received their replacement device and is doing well.

  Patient problems: Dyspnea

  MAUDE report 50216564 ↗
• InjuryAug 7, 2026Failure to Deliver

  It was reported that the patient's device displayed a System Error message and stopped providing oxygen to the patient while out at the market. As a result, the patient was unable to breathe and had to go back to their car. The patient did have a backup oxygen tank, but it was empty. A replacement device was sent to the patient.

  Patient problems: Dyspnea

  MAUDE report 50181289 ↗
• InjuryAug 5, 2026No Flow

  Patient problems: Low Oxygen Saturation

  MAUDE report 50146983 ↗
• InjuryJul 27, 2026Insufficient Flow or Under Infusion

  It was reported that the patient's device was displaying the Low Oxygen and Change Columns messages while traveling. As a result, the patient's oxygen level decreased. The patient did not have a backup at the time of the event. After a couple nights of having this issue, the patient returned home and no longer needed the device. The patient does not have any ongoing issues due to the event.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50045982 ↗
• InjuryJul 10, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE LOW OXYGEN ERROR MESSAGE AND WAS NOT PUTTING OUT ENOUGH OXYGEN WHILE DRIVING. AS A RESULT, THE PATIENT EXPERIENCED SHORTNESS OF BREATH, WEAKNESS, AND DECREASED OXYGEN LEVELS. THE PATIENT DID NOT HAVE A BACKUP DEVICE AT THE TIME. REPLACEMENT COLUMNS WERE SENT TO THE PATIENT AND THERE ARE NO ONGOING COMPLICATIONS DUE TO THE EVENT.

  Patient problems: Dyspnea; Fatigue; Low Oxygen Saturation

  MAUDE report 25785053 ↗
• InjuryJul 7, 2026Failure to Deliver

  IT WAS REPORTED THAT THE PATIENT'S DEVICE STOPPED PRODUCING OXYGEN WHILE THE PATIENT WAS OUT AND THEIR OXYGEN LEVELS DECREASED TO 85%. THE SYSTEM ERROR MESSAGE WAS NOTED. THE PATIENT WENT HOME RIGHT AWAY TO THEIR STATIONARY ONCE THE ISSUE HAPPENED AS THEY HAD NO BACKUP TANK. PATIENT HAS RECEIVED THEIR REPLACEMENT DEVICE AND IS DOING FINE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25736089 ↗
• InjuryJul 7, 2026Failure to Run on Battery

  IT WAS REPORTED THAT THE PATIENT'S DEVICE SHUT OFF BY ITSELF WHEN ATTACHED TO THE BATTERY. BUT WAS WORKING FINE WHEN PLUGGED INTO A WALL OUTLET. IT WAS NOTED THAT THE PATIENT WAS SENT TO THE ICU AS THEY WERE EXPERIENCING DIFFICULTY BREATHING. A REPLACEMENT BATTERY WAS SENT TO THE PATIENT. ALTHOUGH THIS EVENT IS ON THE DEVICE BATTERY, THIS REPORT WILL BE ON THE DEVICE ITSELF. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL.

  Patient problems: Dyspnea

  MAUDE report 25734592 ↗
• InjuryJul 6, 2026Overheating of Device

  IT WAS REPORTED THAT THE PATIENT HAD TO TURN OFF THEIR DEVICE MULTIPLE TIMES AS THE DEVICE WOULD GET TO HOT, LEAVING THE PATIENT UNABLE TO BREATHE WITHOUT OXYGEN. THE PATIENT HAD ANOTHER PORTABLE OXYGEN CONCENTRATOR FOR BACKUP BUT DID NOT HAVE A STATIONARY OXYGEN CONCENTRATOR OR OXYGEN TANK. THE PATIENT HAS SINCE RECEIVED THEIR REPLACEMENT DEVICE AND HAS NO COMPLICATIONS.

  Patient problems: Dyspnea

  MAUDE report 25717874 ↗
• InjuryJul 2, 2026No Flow

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD AN ERROR MESSAGE AND STOPPED PROVIDING OXYGEN. AS A RESULT, THE PATIENT'S LEGS GOT NUMB WHILE THEY WERE WALKING. REPLACEMENT COLUMNS WERE SENT TO THE PATIENT, BUT THAT DID NOT RESOLVE THE ISSUE AND A REPLACEMENT UNIT WAS SENT. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Numbness

  MAUDE report 25698596 ↗
• InjuryJun 24, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT WAS DISPLAYING AN ERROR MESSAGE AND TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. AS A RESULT, THE UNIT WAS NOT OUTPUTTING ENOUGH OXYGEN CAUSING THE PATIENT'S LEVELS TO DROP. THE PATIENT ALSO STATED THAT DUE TO A HEART CONDITION, THIS CAUSED THEIR HEART TO INCREASE. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 25604233 ↗
• InjuryMay 22, 2026Overheating of Device; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S DEVICE GOT HOT AND SHUT DOWN BY ITSELF WHILE AT CHURCH, AND THE PATIENT'S OXYGEN LEVELS DECREASED. PATIENT STATED THE DEVICE GOT SO HOT IT FELT LIKE IT WAS BURNING THEIR SKIN. AS A RESULT, THE PATIENT WENT HOME TO THEIR STATIONARY OXYGEN UNIT. REPLACEMENT DEVICE HAS BEEN RECEIVED AND NO ISSUES HAVE BEEN NOTED WITH THE DEVICE.

  Patient problems: Burn(s); Low Oxygen Saturation

  MAUDE report 25259875 ↗
• InjuryMay 22, 2026No Flow; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD STOPPED WORKING AND WAS NOT PRODUCING ENOUGH OXYGEN. AS A RESULT, THE PATIENT'S OXYGEN LEVELS DROPPED AND THEY HAD TO BE HOSPITALIZED, WHILE AT THE HOSPITAL, THE PATIENT'S OXYGEN WAS BUMPED UP TO 3 LPM AND THEY WERE GIVEN STEROIDS. THEY WERE DISCHARGED AFTER SIX DAYS. A REPLACEMENT UNIT WAS SENT TO THE PATIENT AND IT IS WORKING FOR THEM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25259873 ↗
• InjuryMay 15, 2026Insufficient Flow or Under Infusion; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S UNIT HAD AN ERROR MESSAGE AND MADE A LOUD NOISE. AS A RESULT, THE UNIT WAS NOT PRODUCING ENOUGH OXYGEN AND CAUSED THE PATIENT TO PANIC. THE PATIENT HAD TO STAY AND DO BREATHING EXERCISES FOR SEVERAL HOURS TO CALM DOWN AS THEY DID NOT HAVE ANY BACKUP SOURCES WITH THEM. THERE WERE NO OTHER INTERVENTIONS AT THE TIME. THE PATIENT HAS RECEIVED THE REPLACEMENT UNIT AND IT IS WORKING.

  Patient problems: Anxiety

  MAUDE report 25184547 ↗
• InjuryMay 8, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS DISPLAYING THE SYSTEM ERROR MESSAGE AND THEIR BATTERY KEPT BEEPING WHEN THEY WERE OUTSIDE. AS A RESULT, THE PATIENT STARTED EXPERIENCING 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 25124454 ↗
• InjuryMay 7, 2026Failure to Charge

  IT WAS REPORTED THAT THE PATIENT'S DEVICE BATTERY WAS NOT HOLDING A CHARGE DURING A LOCAL POWER OUTAGE. THE PATIENT'S WIFE WENT OUT TO RENT A GENERATOR, BUT DURING THAT TIME THE PATIENT STARTED EXPERIENCING SHORTNESS OF BREATH. AS A RESULT, THE PATIENT WAS SENT TO THE HOSPITAL AND WAS ADMITTED FOR 3 DAYS.

  Patient problems: Dyspnea

  MAUDE report 25116903 ↗
• InjuryMay 5, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT WHEN THE PATIENT WAS VISITED BY A HOME HEALTHCARE SERVICE, THE WORKERS NOTED THAT THE DEVICE WAS NOT PRODUCING ENOUGH OXYGEN AS IT SHOULD AND THE PATIENT WAS ALSO EXPERIENCING SHORTNESS OF BREATH. AS A RESULT, THE PATIENT WAS SENT TO THE HOSPITAL AND RECEIVED A BACKUP CONCENTRATOR. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED AT THE TIME DUE TO AN UNRELATED UTI. PATIENT HAS SINCE LEFT THE HOSPITAL AND RECEIVED A REPLACEMENT DEVICE AS WELL.

  Patient problems: Dyspnea

  MAUDE report 25086664 ↗
• InjuryApr 24, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ENOUGH OXYGEN FROM THEIR DEVICE AND WAS EXPERIENCING SHORTNESS OF BREATH. THE PATIENT DID NOT HAVE A BACKUP DEVICE AT THE TIME. AS A RESULT, THE PATIENT WENT TO THE HOSPITAL AND WAS ADMITTED FOR 4 DAYS. THE PATIENT WAS GIVEN A REPLACEMENT DEVICE AND IS DOING BETTER.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 24983725 ↗
• InjuryApr 16, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PATIENT'S UNIT ALERTED THEM TO REPLACE THE COLUMNS. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. AS A RESULT, THE PATIENT EXPERIENCED DIFFICULTY BREATHING. REPLACEMENT COLUMNS WERE SENT TO THE PATIENT. THE ISSUE IS AGAINST THE COLUMNS WHICH ARE ACCESSORIES, BUT THE UNIT ITSELF IS LISTED AS THE PRIMARY DEVICE. THE INOGEN TEAM ATTEMPTED TO CONTACT THE PATIENT FOR FURTHER INFORMATION THREE TIMES WITH NO RESPONSE.

  Patient problems: Dyspnea

  MAUDE report 24905215 ↗
• InjuryApr 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S OXYGEN LEVELS DROPPED AND THEY STARTED HAVING DIFFICULTY BREATHING WHEN THEY WERE OUT FOR A WALK. IT WAS NOTED THAT THE DEVICE WAS DISPLAYING THE SYSTEM ERROR MESSAGE AND THAT THE BATTERY SUDDENLY COMPLETELY DEPLETED. AS A RESULT, EMS WAS CALLED AND THEY PROVIDED THE PATIENT WITH OXYGEN. PATIENT WAS TAKEN TO THEIR CAR WHERE THEY HAD HAD THEIR SPARE BATTERY. THE PATIENT IS NOW DOING FINE.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 24897491 ↗