INOGEN EL ICD VRRecalls & reported problems across all models

We found 2 models of INOGEN EL ICD VR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,071 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2016 and Sep 29, 2026 — classified as 5 deaths, 701 injuries, 365 malfunctions.

The most frequently reported specific device problem is “High impedance” (270 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 EL ICD VR problems

INOGEN EL ICD VR models

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

• INOGEN™ EL ICD VR D140

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths823 reports
• INOGEN™ EL ICD VR D141

  Implantable cardioverter defibrillator (non-CRT)
  1 death248 reports

Recent INOGEN EL ICD VR adverse event reports

The 15 most recent reports across all models, 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 25, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903914 ↗
• 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 ↗

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