INOGEN EL ICD DRRecalls & reported problems across all models

We found 2 models of INOGEN EL ICD DR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,314 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 29, 2026 — classified as 6 deaths, 763 injuries, 545 malfunctions.

The most frequently reported specific device problem is “High impedance” (309 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 DR problems

INOGEN EL ICD DR models

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

• INOGEN™ EL ICD DR D142

  Implantable cardioverter defibrillator (non-CRT)
  6 deaths1,017 reports
• INOGEN™ EL ICD DR D143

  Implantable cardioverter defibrillator (non-CRT)
  297 reports

Recent INOGEN EL ICD DR adverse event reports

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

• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) for a consult review of the implantable cardioverter defibrillator (ICD) stored episode due to concerns of oversensing noise. The HCP stated that the episode occurred while the patient was exercising. Upon review, the presenting electrogram (EGM) showed oversensed noise that appears to be inhibiting pacing. Its noted patient is not pacing dependent. TS also noted a drop in right ventricular (RV) lead pacing impedance from 900 to 600ohms which are still considered to be within normal limits (WNL). . TS recommended an in clinic visit for isometric evaluation of the lead. Subsequently, a revision procedure was performed. The ICD was explanted and replaced with a new device. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935349 ↗
• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50795665 ↗
• MalfunctionSep 14, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) and non Boston Scientific right atrial (RA) lead exhibited pacing impedance measurements that were high and out of range. Technical Services (TS) reviewed the available data and noted that no additional occurrences had been observed and that the impedance measurements appeared to have stabilized for the RA. Additionally, it was noted that the right ventricular (RV) lead pacing impedances exhibited a steady climb over time since implant. This CRT-D and RA lead remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748232 ↗
• MalfunctionSep 9, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700311 ↗
• MalfunctionSep 9, 2026Over-Sensing; Pacing Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) presented to the emergency room (ER) due to syncope. The health care professional (HCP) noticed pauses on the electrograms (EGMs) and requested a review of reports from Technical Services (TS). TS reviewed the data and noticed there were some pacemaker mediated tachycardia (PMT) episodes which showed dropped beats along with intermittent t-wave oversensing (TWOS). It was noted the TWOS was also causing dropped beats. TS discussed the patient might be sensitive to the dropped beats and recommended reprogramming options. The device was reprogrammed and no additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Syncope/Fainting

  MAUDE report 50690107 ↗
• MalfunctionSep 9, 2026Over-Sensing; Failure to Read Input Signal

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited far-field p-wave oversensing on the right ventricular (RV) channel. It was also noted there was an RV amplitude that was out of range. Technical Services (TS) reviewed the data and noted the R-wave was marked as ventricular fibrillation (VF) and there was no blanking for the atrial sense. TS recommended performing a defibrillation threshold (DFT) test and suggested reprogramming options. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690106 ↗
• MalfunctionSep 4, 2026Failure to Capture; High impedance; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602144 ↗
• InjurySep 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate anti-tachycardia pacing (ATP) and shocks. Technical Services (TS) was consulted and determined that the patient has been receiving inappropriate ATP and shocks for some time; however, there are no episodes to review as the patient is not enrolled. TS noted that the patient has received multiple inappropriate shocks while active and while sedentary. The local field representative confirmed this has been ongoing, with TS recommending and increased rate and/or duration but further noting that decision to be physician discretion. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50602124 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to unknown circumstances. The replacement was successfully performed and a new device was implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned to the laboratory for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602066 ↗
• MalfunctionSep 4, 2026Interrogation Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was unable to be interrogated using a communicator, with possibly a red call doctor icon (RCD) displayed. Technical Services (TS) was consulted and troubleshooting was performed but it was unsuccessful. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601420 ↗
• InjuryAug 24, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a Code 1003, indicating the voltage was 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. Subsequent review of the shock impedance measurements showed values below 90 ohms. This ICD was configured with a single coil shock lead, and the impedance measurements were obtained during the initial Implant (INIT) test and during delivered 41 J shocks. Additional information indicated that this ICD was explanted and will be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416154 ↗
• InjuryAug 22, 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 50388381 ↗
• InjuryAug 16, 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 50265314 ↗
• InjuryAug 14, 2026High impedance; Pacing Problem; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) was in a dual arrythmia and was found unconscious and not breathing. Technical Services (TS) was called for further review of the stored episode. It was noted that the right ventricular (RV) lead exhibited high out of range shock impedances. Upon review, the presenting electrogram (EGM) showed patient was in a dual arrhythmia and the device delivered bursts of anti-tachycardia pacing (ATP) and shocks. Therapy was exhausted. The shocks were unable to convert the arrhythmia. TS reviewed the daily threshold and impedance measurements trend report and confirmed the RV lead shock impedances were greater than 125 ohms and had been gradually increasing over the years. It was noted that 911 was contacted by patient advocate. No additional adverse patient effects were reported. This ICD and RV lead remain in service.

  Patient problems: Cardiac Arrest; Loss of consciousness

  MAUDE report 50246155 ↗
• MalfunctionAug 12, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229896 ↗

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