INOGEN™ EL ICD VR D140Recalls & reported problems

Summary

The FDA's MAUDE database contains 823 adverse event reports that list this exact device (DI 00802526534201), received between Apr 15, 2016 and Sep 29, 2026 — classified as 4 deaths, 559 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (166 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 823 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938893 ↗
• InjurySep 29, 2026Premature Discharge of Battery

  It was reported that this Implantable Cardioverter Defibrillator (ICD) recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis low voltage fault and that this device power consumption recently began dropping in a gradual fashion. Subsequently, this device was explanted and replaced. A new device was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937004 ↗
• MalfunctionSep 21, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848229 ↗
• MalfunctionSep 20, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834869 ↗
• MalfunctionSep 20, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834819 ↗
• MalfunctionSep 18, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis showed the battery appeared to be depleting more quickly than expected. Device replacement was recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50814678 ↗
• MalfunctionSep 17, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812693 ↗
• MalfunctionSep 16, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796743 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of the system revision due to infection. Reportedly, the patient had a Coronary Artery Bypass Grafting (CABG) and the ejection fraction (EF) had improved. Subsequently, the ICD was removed, and the patient had a blood clot with sepsis anomaly. Furthermore, the patient recovered to the procedures but now had the atrial flutter (AF) with decreased EF. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Atrial Flutter; Sepsis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 50784911 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of a system revision due to infection. There were no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50733327 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a code 1003, which states that the voltage is too low for projected remaining capacity. A request was made to have data from this device analyzed. Data analysis confirmed that the code appears consistent with premature battery depletion due to hydrogen degradation of the bypass capacitors. Device replacement was recommended. This device remains in service at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659814 ↗
• MalfunctionSep 7, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50650667 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of a system revision due to infection. There was no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50612373 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with implantable cardioverter defibrillator (ICD) felt as though the lead wire was pulling out and was experiencing sharp pain and dizziness. TS referred the patient to the physician for further evaluation. To date, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: Dizziness; Pain

  MAUDE report 50610690 ↗
• InjurySep 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate shock and anti-tachycardia pacing (ATP) therapy for supraventricular tachycardia (SVT). Technical Services (TS) provided reprograming options. This device remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50602100 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602071 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that during a review of the recorded episodes of this implantable cardioverter defibrillator (ICD), an isolated noise oversensing episode was observed. Technical Services (TS) noted that the noise was likely from electromagnetic interference during a procedure, since therapy was programmed off for the episode. No adverse patient effects were reported. This device remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601131 ↗
• InjuryAug 18, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis showed the battery appeared to be depleting more quickly than expected due to an internal battery short. This ICD was explanted, replaced with a different model and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304645 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was part of the system revision due to infection. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50261993 ↗
• MalfunctionAug 14, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50248293 ↗
• MalfunctionAug 12, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223130 ↗
• MalfunctionAug 11, 2026Premature Discharge of Battery; Noise, Audible

  It was reported that this implantable cardioverter defibrillator (ICD) emitted beeping tones and recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified that the power consumption is increasing in a gradual fashion. Device replacement was recommended. This device remains in service at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209672 ↗
• InjuryAug 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate anti-tachycardia pacing (ATP) and six shocks due to supraventricular tachycardia (SVT). Reprograming of the device was performed. This device remains in service. No further adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50144377 ↗
• InjuryAug 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered rounds of inappropriate anti-tachycardia pacing (ATP) due to an episode of sinus tachycardia. The device remains in service. No adverse patient effects were reported.Additional information obtained of six ATP sequences and six shocks for a rhythm with gradual onset and ventricular rates below the programmed therapy threshold. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122481 ↗
• MalfunctionJul 27, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50003503 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · 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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• 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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551