RESONATE™ EL ICD DR D433Recalls & reported problems

Summary

The FDA's MAUDE database contains 965 adverse event reports that list this exact device (DI 00802526588075), received between Apr 27, 2018 and Sep 29, 2026 — classified as 4 deaths, 596 injuries, 365 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (202 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 965 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Capture; High impedance; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range impedance measurements and a signal artifact monitoring (SAM) episode due to artifact related to the minute ventilation (MV) feature signal on its right atrial (RA) lead. Additionally, there was loss of capture (LOC) for its RA lead following the SAM episode. Technical Services (TS) was consulted and discussed stored data. The device will have its programming adjusted and the patient will continue to be monitored. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933500 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812177 ↗
• InjurySep 15, 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 and erosion. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 50768536 ↗
• MalfunctionSep 9, 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. Technical Services (TS) recommended device replacement or planned battery reassessment. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692350 ↗
• InjurySep 9, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the health care professional (HCP) requested a review of this implantable cardioverter defibrillator (ICD), as it potentially delivered inappropriate therapy for an atrial tachycardia. Technical Services (TS) reviewed the stored data and noted that the recorded ventricular episodes appeared consistent with atrial fibrillation (AF) with rapid ventricular response (RVR) as the atrial rate was greater than the ventricular rate, and the rhythm appeared to be atrial-driven, with the shocks delivered the rhythm was successfully converted. The device appeared to be functioning as programmed; however, the therapy may have been inappropriate given the underlying atrial arrhythmia. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50691669 ↗
• MalfunctionSep 9, 2026Over-Sensing

  It was reported that during a hospital visit, the health care professional (HCP) called Technical Services (TS) for a consult review of this implantable cardioverter defibrillator (ICD) presenting electrogram (EGM). Upon review, right atrial (RA) far field oversensing which led to inappropriate Atrial Tachy Response (ATR) was observed. TS provided the HCP with programming recommendations. At this time, the ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691012 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50654257 ↗
• MalfunctionSep 4, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615126 ↗
• MalfunctionSep 4, 2026Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) was exhibiting farfield oversensing. Technical Services (TS) reviewed the data with the field personnel and noticed the premature ventricular contraction (PVC) burden for the patient has increased drastically over time. The programming was adjusted for this device. The ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612122 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited oversensing of electromagnetic interference (EMI) noise that resulted in a false Signal Artifact Monitor (SAM) event. Minute ventilation (MV) was disabled by the SAM event. Technical Services (TS) confirmed measurements were in range. Also, TS suspected the patient had another implanted device such as a spinal cord stimulator (SCS) or Deep Brain Stimulation (DBS) due to observing persistent noise on the shock electrogram (EGM). There was no oversensing noted on the pacing and sensing channels. TS recommended the health care professional (HCP) ask the patient what they were doing when the noise was observed. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602242 ↗
• 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 were no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50601110 ↗
• 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 were no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50601108 ↗
• MalfunctionAug 25, 2026Pacing Problem; Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) delivered nine bursts of anti-tachycardia pacing (ATP) as inappropriate therapy due to undersensing of the patients atrial flutter (AF). Technical Services (TS) was consulted and reviewed stored data. TS discussed available programming options based on the patients rhythm. This device remains in serv ice. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50423822 ↗
• InjuryAug 24, 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 50421702 ↗
• MalfunctionAug 19, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326225 ↗
• InjuryAug 19, 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 50320610 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50314604 ↗
• InjuryAug 17, 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 50274591 ↗
• MalfunctionAug 14, 2026High impedance; Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246157 ↗
• MalfunctionAug 13, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232302 ↗
• InjuryAug 10, 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 was hospitalized and was diabetic. Subsequently, the physician wanted the MRI (Magnetic Resonance Imaging) performed on the patient to check the spread of the toe infection. No additional adverse patient effects were reported. The ICD remains implanted.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50190527 ↗
• MalfunctionAug 10, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189691 ↗
• InjuryAug 7, 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 systemic infection then the extraction was successful. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50172422 ↗
• InjuryAug 4, 2026Pacing Problem; Interrogation Problem

  It was reported that the physician was unable to interrogate this implantable cardioverter defibrillator (ICD) device post an ablation procedure. The physician reported attempting to interrogate with multiple programmers and troubleshooting with magnets but was unable to interrogate the device. The device was programmed to ventricular pacing with no evidence of pacing but patient has intrinsic rhythm. Technical Services (TS) was consulted for troubleshooting assistance. Additional troubleshooting attempts were unsuccessful. Subsequently, a device replacement procedure was performed, this ICD was explanted and replaced with a new device successfully. No additional adverse patient effects were reported. This ICD was returned to facility and is awaiting analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131916 ↗
• InjuryAug 3, 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 undergone an echocardiogram then the physician found the vegetation. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50112141 ↗

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-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