INOGEN™ X4 CRT-D G148Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,252 adverse event reports that list this exact device (DI 00802526534591), received between Apr 21, 2016 and Sep 30, 2026 — classified as 8 deaths, 724 injuries, 520 malfunctions.

The most frequently reported specific device problem is “High impedance” (272 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,252 reports, 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 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 ↗
• InjuryJun 25, 2026High impedance; Data Problem; High Capture Threshold

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED A FLAT EGM FOR THE NON BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD CHANNEL. THIS DEVICE HAD 44% RIGHT VENTRICULAR (RV) PACING AND 100% LV PACING, AND THE LV LEAD WAS PROGRAMMED TO SUBTHRESHOLD MEASUREMENT OF 0.1V. THE LV LEAD ALSO EXHIBITED INTERMITTENTLY HIGH, OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS, AND THE PATIENT COMMENTED THAT THE LV LEAD MAY HAVE DISLODGED. HOWEVER, IT WAS UNCLEAR WHY BIVENTRICULAR (BIV) WAS STILL PROGRAMMED, WHILE THE LV WAS PROGRAMMED SUBTHRESHOLD. THE PREVIOUS LV THRESHOLD MEASUREMENT WAS 5V. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25617526 ↗
• InjuryJun 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. THIS CRT-D AS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25478164 ↗
• MalfunctionJun 10, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING ON THE LEFT VENTRICULAR (LV) CHANNEL. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED PACING INHIBITION ON THE PRESENTING ELECTROGRAM (EGM) . NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25463967 ↗
• MalfunctionJun 2, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) NOTED THERE WAS NOT ENOUGH DATA TO KNOW IF THIS WAS A GRADUAL INCREASE. THE CRT-D WAS NEARING THE ELECTIVE REPLACEMENT INDICATOR (ERI), SO TS RECOMMENDED POTENTIAL REPROGRAMMING AND ADVISED THE PHYSICIAN TO CONSIDER THE RV LEAD REPLACEMENT WHEN THE DEVICE DOES REACH END OF LIFE (EOL). THE CRT-D AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368152 ↗
• MalfunctionJun 1, 2026Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING AND A LOWER BIVENTRICULAR PACING PERCENTAGE. TECHNICAL SERVICES (TS) ASSESSED THE PACEMAKER MEDIATED TACHYCARDIA EPISODE AND CONFIRMED THE OVERSENSING; HOWEVER, AFTER REVIEW OF THE PRESENTING ELECTROGRAM, DETERMINED THE LOWER BIVENTRICULAR PACING PERCENTAGE WAS DUE TO PREMATURE VENTRICULAR CONTRACTIONS. THE FIELD REPRESENTATIVE INCREASED THE SENSITIVITY OF THE DEVICE AND WILL CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349229 ↗
• MalfunctionMay 29, 2026Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) ASKING ABOUT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE HCP NOTED THIS CRT-D EXHIBITED LOW AMPLITUDES ON THE RIGHT ATRIAL (RA) CHANNEL. TS NOTED THERE WAS NOT UNDERSENSING ON THE PRESENTING ELECTROGRAM (EGM) BUT NOTED THERE WAS FAR-FIELD OVERSENSING. THIS CRT-D REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333508 ↗
• MalfunctionMay 28, 2026Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A REVIEW OF REPORTS FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). UPON REVIEW, TS NOTED THIS CRT-D EXHIBITED FAR-FIELD OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319686 ↗
• InjuryMay 22, 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 STAPHYLOCOCCUS AUREUS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-D WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 25257449 ↗
• MalfunctionMay 21, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING OF ATRIAL SIGNALS ON THE LV CHANNEL. THE OVERSENSING CAUSED PACING INHIBITION ON THE LV LEAD. TECHNICAL SERVICES (TS) DETERMINED LV SENSING WAS OFF PRIOR TO THE OVERSENSING EPISODE. TS SUSPECTED LV SENSING WAS TURNED ON FOR IN-CLINIC TESTING AND WAS NOT TURNED OFF AFTER. TS RECOMMENDED REPROGRAMMING LV SENSING OFF. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243965 ↗
• MalfunctionMay 14, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SUSPECTED PREMATURE BATTERY DEPLETION (PBD) AND THE LONGEVITY DROPPED FROM 1 YEAR TO 3 MONTHS IN A SPAN 3 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT LOOKS LIKE THERE IS A CAPACITOR REFORM AND LIKELY BROUGHT THE VOLTAGE LOW ENOUGH TO PROJECT 3 MONTHS. TS INFORMED THAT IT COULD TRIGGER TO ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO CHARGE TIME AND DOES NOT THINK THAT THIS IS ABNORMAL DEPLETION. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178953 ↗
• InjuryMay 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 WITH SEPSIS AND URINARY TRACT INFECTION (UTI). THE PATIENT WAS TREATED WITH ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25140173 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.