VIGILANT™ EL ICD VR D232Recalls & reported problems

Summary

The FDA's MAUDE database contains 750 adverse event reports that list this exact device (DI 00802526587788), received between Jan 16, 2018 and Sep 28, 2026 — classified as 8 deaths, 522 injuries, 220 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (161 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 750 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50919284 ↗
• InjurySep 17, 2026Insufficient Device Problem Information

  It was reported by the healthcare professional (HCP) that this implantable cardioverter-defibrillator (ICD) was off, and attempts were made to restore device operation. To date, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798088 ↗
• MalfunctionSep 14, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) device recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. Data was sent for engineering analysis. Analysis showed that the battery voltage is dropping rapidly and unpredictably triggering the low voltage anomaly. Device replacement was suggested. To date, this device remains in service. No adverse patient effects were reported.Additional information received indicates that the device was explanted and a new device was successfully placed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750786 ↗
• MalfunctionSep 10, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724923 ↗
• InjurySep 10, 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 50713626 ↗
• InjurySep 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. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50712221 ↗
• InjurySep 4, 2026Pacing Problem; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50621099 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50613289 ↗
• InjurySep 4, 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 identified that the power consumption was increasing in a gradual fashion. Device replacement was recommended. 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 50602446 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) experienced a syncopal episode. Technical Services (TS) was consulted and reviewed the device data, finding no stored events corresponding to the reported episode. TS noted that the device appeared to be functioning as programmed and successfully faxed the review results to the healthcare professional (HCP) for further evaluation. This device remains in service. No adverse patient effects were reported.

  Patient problems: Syncope/Fainting

  MAUDE report 50566976 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) stated experiencing pain after striking the implant site with a wrench. The patient also reported significant weight loss and observed that a portion of the implanted device protruded when rotating the body. Technical Services (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: Implant Pain; Pocket Erosion

  MAUDE report 50550300 ↗
• InjuryAug 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) received anti-tachycardia pacing (ATP) and shock therapy that may have been inappropriate. Technical Services (TS) reviewed the stored data and noted the irregular ventricular rate of approximately 175-180 beats per minute. was suggestive of atrial fibrillation (AF) with rapid ventricular response (RVR), two ATP bursts and three electric shocks were delivered. The device was operating as programmed. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50424456 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Failure to Read Input Signal; Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376473 ↗
• InjuryAug 20, 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 50343447 ↗
• 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. Reportedly, the patient also had pocket erosion and dehiscence. Subsequently, one of the leads were surgically abandoned. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 50284710 ↗
• InjuryAug 13, 2026Insufficient Device Problem Information

  It was reported by the patient advocate that, after an ablation procedure, this implantable cardioverter defibrillator (ICD) was turned off and likely not have been reenabled. Additionally, the patient advocate reported that the patient was in the emergency room waiting area. A Boston Scientific Field Clinical Representative was paged, and the patient was referred to the managing physician for evaluation. To date, this ICD remains in service. No adverse patient effects were reported.Additional information indicated that no patient injury or adverse clinical consequences occurred. No intervention was required, and the patient remained stable throughout the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230549 ↗
• InjuryAug 5, 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 50148155 ↗
• MalfunctionAug 4, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128899 ↗
• InjuryAug 4, 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 50126573 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to a large hematoma that developed several months post implant. The physician was uncertain whether infection was present because no pus was observed and the delayed onset was atypical for an implant related infection. No new device was implanted, and this ICD was not returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 50103894 ↗
• MalfunctionJul 30, 2026Inappropriate/Inadequate Shock/Stimulation

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

  MAUDE report 50091894 ↗
• InjuryJul 30, 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 50089583 ↗
• InjuryJul 27, 2026Signal Artifact/Noise

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited noisy signals. Technical Services (TS) reviewed the stored ventricular tachycardia (VT) episodes and noted noise without oversensing. TS suspected diaphragmatic noise and recommended to continue to monitor. No adverse patient effects were reported. This ICD remains in service.Additional information was received that this ICD was successfully explanted and replaced. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50040887 ↗
• MalfunctionJul 22, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25908894 ↗
• InjuryJul 21, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN ABRUPT ONSET OF VENTRICULAR TACHYCARDIA (VT). ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, WAS INEFFECTIVE, AND ACCELERATED THE RHYTHM INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. A SINGLE SHOCK WAS DELIVERED WHICH CONVERTED THE ARRYTHMIA. IT WAS NOTED THIS HAD OCCURRED SEVERAL TIMES IN THE PAST AFTER THE PATIENT MISSED A DOSE OF THEIR BETA BLOCKER. TECHNICAL SERVICES (TS) CONFIRMED LEAD DIAGNOSTICS AND SHOCK IMPEDANCE WERE IN RANGE. TS RECOMMENDED ENSURING THE PATIENT WAS TAKING THEIR MEDICATION AND DISCUSSED REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 25897163 ↗

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