INOGEN™ EL ICD DR D142Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,017 adverse event reports that list this exact device (DI 00802526534249), received between Apr 22, 2016 and Sep 16, 2026 — classified as 6 deaths, 612 injuries, 399 malfunctions.

The most frequently reported specific device problem is “High impedance” (186 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,017 reports, in the reporter's own words as published by the FDA.

• 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, 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 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 ↗
• 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 11, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216515 ↗
• MalfunctionAug 10, 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 that the power consumption was increasing in a gradual fashion. Device replacement was recommended. As of this time, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196765 ↗
• MalfunctionJul 29, 2026High impedance; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072973 ↗
• InjuryJul 27, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; Unexpected Therapeutic Results

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) system experienced ventricular fibrillation (VF) for which multiple shocks were delivered. One shock achieved rhythm conversion; however, the patient went back in VF. Therapy was delivered until it was exhausted. It was noted that the patient lost consciousness and sustained bumps and bruises. Technical Services (TS) was consulted and discussed that a code 1005 was recorded, due to high out of range shock lead impedance measurements greater than 125 Ohms during attempted shock delivery. TS recommended that the patient be considered unprotected and that the system be evaluated and replaced at the physicians discretion. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Bruise/Contusion; Loss of consciousness; Ventricular Fibrillation

  MAUDE report 50011411 ↗
• InjuryJul 21, 2026Pacing Problem; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ONE ANTI-TACHYCARDIA PACING (ATP) AND EIGHT SHOCKS. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW OF THE AVAILABLE INFORMATION IT WAS SUSPECTED THE THERAPY WAS INAPPROPRIATELY DELIVERED DUE TO ATRIAL DRIVEN RHYTHMS. IN ADDITION, IT WAS NOTED THAT THERAPY WAS EXHAUSTED AND IT DID NOT CONVERT THE PATIENT RHYTHM. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25897559 ↗
• MalfunctionJul 14, 2026Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A SIGNAL ARTIFACT MONITOR (SAM) DUE TO NOISE DURING A SURGICAL PROCEDURE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820952 ↗
• MalfunctionJul 6, 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 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 25728390 ↗
• MalfunctionJul 3, 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 CONFIRMED THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25708320 ↗
• MalfunctionJun 26, 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 CONFIRMED THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634990 ↗
• MalfunctionJun 22, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS, WITH THE PATIENT EXPERIENCING ATRIAL FLUTTER THE SAME DAY. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED THE EVENTS WERE UNRELATED. TS FURTHER DETERMINED THE IMPEDANCE BEHAVIOR APPEARED TO BE A SPRING CONTACT ISSUE DUE TO THE DEVICE HEADER BEING OLDER AND A NON-BOSTON SCIENTIFIC LEAD WAS IMPLANTED IN THE SYSTEM. TS NOTED THAT IMPEDANCE SPIKES HAD PREVIOUSLY OCCURRED; HOWEVER, THE DEVICE HAS CONTINUED TO FUNCTION AS PROGRAMMED AND THE SYSTEM WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580234 ↗
• InjuryJun 19, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ATRIAL PACING LEAD IMPEDANCE OUT-OF-RANGE CONDITION AND ATRIAL TACHY RESPONSE (ATR) EPISODES DEMONSTRATING ATRIAL FLUTTER WITH ASSOCIATED NOISE. WHILE ON THE PROCEDURE TABLE PREPARING FOR A WATCHMAN PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC ARREST. DEVICE REVIEW SHOWED NO STORED EPISODES OTHER THAN THE ONGOING ATRIAL FLUTTER. A DECREASE IN INTRINSIC ATRIAL AMPLITUDE WAS ALSO OBSERVED AT THE TIME OF THE EVENT; HOWEVER, THE PATIENT HAD A HISTORY OF CHRONIC ATRIAL FLUTTER. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 25563854 ↗
• MalfunctionJun 15, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE. TECHNICAL SERVICES (TS) REVIEWED THE DATA, THE VALUE WAS AT 131 OHMS AND THE AVERAGE WAS WITHIN RANGE. TS RECOMMENDED PROGRAMMING OPTIONS AND CONTINUED MONITORING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504754 ↗
• MalfunctionJun 11, 2026Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD LOW OUT OF RANGE IMPEDANCE MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD. THERE WERE ALSO NOISY SIGNALS ON THE LEAD THAT WAS NOTED WHEN THE PATIENT WAS MOVING. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING CHANGES FOR THIS LEAD. THIS ICD AND RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466703 ↗
• InjuryJun 10, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK AND THE PATIENT WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT FELT ANXIOUS THAT THE DEVICE WOULD INAPPROPRIATELY SHOCK AGAIN. IT WAS ALSO NOTED THE PATIENT WAS SCHEDULED FOR AN ABLATION. THIS PATIENT WAS REFERRED TO THE DOCTOR. THIS ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 25459232 ↗
• MalfunctionMay 25, 2026High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS TO PERFORM IN CLINIC. TS STATED LEAD REPLACEMENT SHOULD BE CONSIDER IF THE MEASUREMENTS REACH GREATER THAN 150 OHMS. IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS ALSO FOLLOW THIS PATTER; HOWEVER, NOT OUT OF RANGE. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272482 ↗

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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• 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-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-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-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-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