INOGEN X4 CRT-DRecalls & reported problems across all models

We found 2 models of INOGEN X4 CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,453 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 30, 2026 — classified as 14 deaths, 856 injuries, 583 malfunctions.

The most frequently reported specific device problem is “High impedance” (324 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 X4 CRT-D problems

INOGEN X4 CRT-D models

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

• INOGEN™ X4 CRT-D G148

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths1,252 reports
• INOGEN™ X4 CRT-D G146

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  6 deaths201 reports

Recent INOGEN X4 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 30, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered potentially inappropriate anti-tachycardia pacing (ATP) and a shock. The onset of the arrythmia appeared to possibly be atrial flutter with rapid ventricular response (RVR). The ATP possibly put the patient into ventricular tachycardia (VT). The shock delivered converted the VT, but the atrial flutter remained. Technical Services (TS) discussed possible reprogramming options for this device. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s); Tachycardia

  MAUDE report 50947458 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50910871 ↗
• InjurySep 18, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potential inappropriate therapy for due to atrial undersensing. Technical Services (TS) reviewed the stored data and noted the atrial undersensing resulted in the device determined the ventricular rate was greater than the atrial rate, 13 anti-tachycardia pacing (ATP) bursts and three electric shocks were delivered, one of the ATP bursts accelerated the rhythm to ventricular fibrillation (VF), but the rhythm was ultimately converted. TS advised evaluation of the atrial lead and recommended reprogramming adjustments. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 50813000 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced low blood pressure and low heart rate. In addition, the patient also experienced a racing heart while playing. The patient was hospitalized and was determined to be dehydrated. As of this time, this CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Bradycardia; Dehydration; Low Blood Pressure/ Hypotension; Palpitations

  MAUDE report 50774734 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  It was reported that electrogram (EGM) review was requested for this cardiac resynchronization therapy defibrillator (CRT-D) due to observed pauses less than two seconds. Upon review, each pause was preceded by an atrial fibrillation (AF) beat. When atrial flutter response (AFR) is triggered, post-ventricular atrial refractory period (PVARP) is extended and the ventricular pace (Vp) cannot track the p-wave. This appears related to farfield oversensing marked as premature atrial contraction (PAC), just prior. Technical Services (TS) discussed troubleshooting options and programming considerations, recommending extending the blanking from Smart to Fixed and turning off AFR. Additional information received reported that the recommended programming changes were completed. This CRT-D remains in service, and will continue to be monitored. No additional adverse patient effects were reported.

  Patient problems: Bradycardia

  MAUDE report 50748339 ↗
• MalfunctionSep 10, 2026Premature Discharge of Battery

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded a Code 1003, indicative of battery voltage being too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis showed that the battery appeared to be depleting more quickly than expected. Device replacement was recommended. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704859 ↗
• MalfunctionSep 8, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671514 ↗
• MalfunctionSep 7, 2026Failure to Capture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658246 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50569723 ↗
• InjuryAug 11, 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 50202745 ↗
• InjuryAug 6, 2026Over-Sensing; Under-Sensing

  It was reported that during a routine generator change procedure, the presenting electrogram (EGM) of this cardiac resynchronization therapy defibrillator (CRT-D) showed farfield atrial oversensing and undersensing of atrial flutter. Technical Services (TS) was contacted and provided programming optimization recommendations. The generator change was completed successfully with the CRT-D explanted due to normal battery depletion (NBD) and replaced with a new device and the right atrial (RA) lead remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161818 ↗
• InjuryJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem; Delayed Charge Time; Data Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded a code 1007 indicative of exceeded charge time limit. Additionally, the remote monitoring was disabled due to limited battery capacity. Technical Services (TS) was consulted and upon data review discussed that the device set End of Life (EOL) battery status and remote monitoring disable due to a charge timeout and suspected that the device was not capable of holding charge. TS mentioned to consider the patient unprotected and recommended to program the tachy therapy off. Subsequently the field representative confirmed that tachy therapy had been disable with a magnet. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057297 ↗
• InjuryJul 7, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE THERAPY DUE TO AN ATRIAL DRIVEN EVENT. THE DEVICE DELIVERED ONE ELECTRIC SHOCK AND THREE BURSTS OF ANTI-TACHYCARDIA PACING (ATP). ADDITIONALLY, IT WAS NOTED THAT ONCE ATP WAS DELIVERED, THE RHYTHM ACCELERATED INTO A VENTRICULAR TACHYCARDIA (VT). SUBSEQUENTLY, AN ELECTRIC SHOCK WAS DELIVERED AND CONVERTED THE RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s); Tachycardia

  MAUDE report 25740436 ↗
• InjuryJul 6, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, GREATER THAN 127 OHMS IN THE RIGHT VENTRICULAR (RV) LEAD. DUE TO THE GRADUALLY RISING SHOCK IMPEDANCE MEASUREMENTS, THIS DEVICE WAS DEACTIVATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728132 ↗
• MalfunctionJul 2, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FELT KIND OF WEIRD ON THE BATTERY LIFE GOING DOWN AND STUCK ON 1.5 YEARS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25689872 ↗

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