INOGEN CRT-DRecalls & reported problems across all models

We found 2 models of INOGEN CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 549 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Sep 23, 2026 — classified as 3 deaths, 284 injuries, 262 malfunctions.

The most frequently reported specific device problem is “High impedance” (211 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INOGEN CRT-D problems

INOGEN CRT-D models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INOGEN™ CRT-D G141

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death415 reports
• INOGEN™ CRT-D G140

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths134 reports

Recent INOGEN CRT-D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50873067 ↗
• MalfunctionAug 28, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Battery Problem

  Patient problems: Asystole

  MAUDE report 50509690 ↗
• InjuryAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was found to be operating in Safety Mode. It was noted that Safety Mode was identified only after the device had been explanted and interrogated on the procedure table. Prior to explant, the local company representative had programmed tachycardia therapy off. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326202 ↗
• MalfunctionMay 17, 2026Interrogation Problem

  IT WAS REPORTED THAT DURING AN IN-OFFICE VISIT THERE WAS DIFFICULTY INTERROGATING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING EFFORTS AND PERFORMED. HOWEVER, THE CRT-D WAS UNABLE TO BE INTERROGATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196742 ↗
• InjuryMay 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WANTED TO KNOW IF THERE WAS ANY ACTIVITY ON THE DEVICE BECAUSE THEY EXPERIENCED A SYNCOPAL EPISODE AFTER PULLING OVER ON THE SIDE OF THE ROAD WHILE DRIVING. IT WAS NOTED THAT THE PATIENT HAD A RECENT MEDICATION SWITCH. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR PHYSICIAN. THIS CRT-D REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25186866 ↗
• InjuryMay 12, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POTENTIALLY ACCELERATED THE PATIENT INTO VENTRICULAR TACHYCARDIA (VT). THE PATIENT REPORTED HAVING TUNNEL VISION WHILE SITTING DOWN. THE DEVICE DELIVERED THERAPY THAT CONVERTED THE RHYTHM AND THE PATIENT WAS TOLD TO VISIT THE EMERGENCY ROOM (ER). TECHNICAL SERVICES (TS) REVIEWED THE EVENT AND RECOMMENDED POTENTIAL PROGRAMMING CHANGES FOR THE DEVICE. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Presyncope; Tachycardia

  MAUDE report 25154979 ↗
• MalfunctionMay 5, 2026Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO EXHIBIT LOSS OF CAPTURE (LOC) AND LEFT VENTRICULAR (LV) PACING DELAY. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW OF THE AVAILABLE INFORMATION TS WAS NOT ABLE TO DETERMINE IF LOC WAS PRESENT. FURTHER IN CLINIC EVALUATION WAS RECOMMENDED. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088186 ↗
• MalfunctionApr 6, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN INAPPROPRIATE SHOCK. THE PATIENT WENT INTO A VENTRICULAR TACHYCARDIA (VT) EPISODE BUT THEIR RHYTHM BROKE, AND THE CHARGE DIVERTED. THE PATIENT WENT INTO A VT EPISODE AGAIN, AND THE RHYTHM BROKE AGAIN BEFORE THE CHARGE COMPLETED. THE PATIENT WENT INTO A VT EPISODE FOR A THIRD TIME, BUT THEIR RHYTHM BROKE AGAIN; HOWEVER, A SHOCK WAS DELIVERED. THE HEALTH CARE PROFESSIONAL (HCP) QUESTIONED WHY THE PATIENT GOT SHOCKED. TECHNICAL SERVICES (TS) EXPLAINED THE DEVICE CANNOT HAVE TWO DIVERTS IN A ROW AND RECOMMENDED REPROGRAMMING OPTIONS. THIS DEVICE WAS REPROGRAMMED AND IT WAS NOTED MEDICATION WOULD BE ADDRESSED WITH THE PATIENT. THIS CRT-D REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24794308 ↗
• MalfunctionMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1003. AS OF THIS TIME DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725354 ↗
• MalfunctionMar 24, 2026Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT DURING VENTRICULAR TACHYCARDIA (VT) ABLATION THE PATIENT EXPERIENCED A TRANSIENT LOSS OF CAPTURE WHILE PROGRAMMED IN DOO MODE. SWITCHING TO VOO IMPROVED CAPTURE, AND FUNCTION WAS NORMAL BEFORE AND AFTER DELIVERY OF RADIOFREQUENCY ENERGY. TECHNICAL SERVICES DISCUSSED THE DEFIB DETECT CIRCUITRY, NOTING ITS ROLE IN TRUNCATING PACING DURING ABLATION. A REPRESENTATIVE WAS PRESENT AT BEDSIDE PERFORMING DEVICE EVALUATION, AND THE PATIENT IS NOT PACEMAKER DEPENDENT. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678912 ↗
• MalfunctionMar 4, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED MONITORING THE IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-D WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512898 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D REMAINS IN SERVICE.ADDITIONAL INFORMATION INDICATES THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 24415308 ↗
• MalfunctionJan 9, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INAPPROPRIATE MODE SWITCHES TO ATRIAL TACHY RESPONSE (ATR) DUE TO OVERSENSING OF NOISY SIGNALS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026685 ↗
• InjuryDec 9, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1005 INDICATIVE OF AN OPEN CIRCUIT CONDITION. THE PATIENT EXPERIENCED TWO EPISODES OF VENTRICULAR FIBRILLATION (VF). ON BOTH EPISODES, THE PATIENT RECEIVED SEVEN SHOCKS WHICH DID NOT CONVERT AND MANAGED TO CONVERT ON THE EIGHTH SHOCK. THEREFORE, THE PATIENT WAS IN VF FOR APPROXIMATELY THREE MINUTES. ADDITIONALLY, THE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO BE HIGH WITHIN RANGE INCREASING GRADUALLY IN THE RIGHT VENTRICULAR (RV) CHANNEL. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 23758684 ↗
• InjuryDec 3, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ABOVE 200 OHMS ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW IT WAS NOTED THAT THERE WAS NOISE ON THE RV LEAD AND NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD, CAUSING OVERSENSING AND PACING INHIBITION ON THE LV CHANNEL. POSSIBLE LOSS OF CAPTURE (LOC) AND A SUSPECTED FRACTURE WAS ALSO NOTED ON THE RV CHANNEL. TS ADVISED ON FURTHER IN OFFICE EVALUATION OF THE SYSTEM. AS A RESULT, THIS CRT-D SYSTEM WAS REPROGRAMMED WITH TACHY THERAPIES OFF AND TO EXCLUDE THE RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711067 ↗

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