VIGILANT™ EL ICD DR D233Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,563 adverse event reports that list this exact device (DI 00802526587801), received between Mar 20, 2018 and Sep 28, 2026 — classified as 9 deaths, 970 injuries, 584 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (416 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 1,563 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Signal Artifact/Noise; High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) recorded two Signal Artifact Monitor (SAM) episodes. Technical Services (TS) reviewed the data and discussed both SAM episodes revealed high out of range pacing impedance measurements on the right ventricular (RV) lead. TS also discussed there was an induction episode prior to the SAM episodes and suspected these episodes could be false due to some sort of electromagnetic interference (EMI) or ablation. TS recommended evaluating the SAM function. TS also noted after the SAM episodes, there were non-sustained episodes and the device had normal sensing. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913963 ↗
• MalfunctionSep 25, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905895 ↗
• MalfunctionSep 24, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891656 ↗
• InjurySep 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered an inappropriate burst of anti-tachycardia pacing (ATP) and three inappropriate shocks. Technical Services (TS) was consulted and agreed with the local field representative that the shocks were delivered for supraventricular tachycardia. TS discussed proposed changes to the rate cutoff and discriminator changes in the ventricular tachycardia monitor only zone with the physician. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50883721 ↗
• InjurySep 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered an inappropriate shock due to a supraventricular tachycardia (SVT). Technical Services (TS) recommended reprogramming to change from tachy zone to a shock box so they can treat the patient with medicines or ablation. Additional information received approximately four years later reported that this ICD delivered three bursts of anti-tachycardia pacing (ATP) and a single shock due to SVT. The shock broke the SVT and normal sinus rhythm resumed. Technical Services (TS) discussed troubleshooting options and programming considerations. The ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50871535 ↗
• MalfunctionSep 23, 2026Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) displayed a Red Call Doctor alert. Technical Services (TS) reviewed the available information and noted that no corresponding alert was identified in the device data. However, the advocate for the patient maintained that the alert had been observed. TS advised the patient to follow up with their treating clinic for further evaluation and investigation of the reported alert. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863877 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Syncope/Fainting

  MAUDE report 50830961 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50828417 ↗
• MalfunctionSep 18, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820539 ↗
• InjurySep 17, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50812470 ↗
• InjurySep 17, 2026Device Alarm System

  It was reported that this implantable cardioverter defibrillator (ICD) was suspected to emit beeping tones even though the physician shut off the alarms after a surgery on this ICD. The Boston Scientific Technical Services consultant discussed that the communicator could not beep but the device could. The patient was referred to the physician to confirm if device was beeping. As of this time, this ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810132 ↗
• MalfunctionSep 17, 2026Unexpected Therapeutic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809848 ↗
• InjurySep 17, 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 50809488 ↗
• InjurySep 17, 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 50801636 ↗
• 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. No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50783089 ↗
• MalfunctionSep 15, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775737 ↗
• MalfunctionSep 15, 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 voltage has indications of irregular discharge. 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 50775282 ↗
• MalfunctionSep 14, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50763903 ↗
• MalfunctionSep 14, 2026Pacing Problem; Defibrillation/Stimulation Problem

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potential inappropriate therapy for an atrial tachycardia (AT). Technical Services (TS) reviewed stored episode and determined that the device delivered inappropriate anti-tachycardia pacing (ATP) burst, the burst accelerated the ventricular rate into the ventricular tachycardia (VT) detection zone and became very stable, resulting in therapy delivery. Review of the stored electrograms (EGMs) suggested that the rhythm was atrial fibrillation (AF) with rapid ventricular response (RVR). No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Tachycardia

  MAUDE report 50754168 ↗
• MalfunctionSep 11, 2026Failure to Capture

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) called in due to interrogation issues with the home monitor. Technical Services (TS) reviewed and found there was a recent transmission with no noted episodes. The tele monitor displayed there was a failure to capture and the rate dropped below the lower rate limit into the 40s. The rate went back to the 60s. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: Bradycardia

  MAUDE report 50734245 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma

  MAUDE report 50724762 ↗
• InjurySep 9, 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 50695666 ↗
• MalfunctionSep 8, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted and discussed stored data was as measurements trends, with monitoring recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668688 ↗
• InjurySep 8, 2026Over-Sensing; Pacing Problem

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited T wave oversensing that resulted in one burst of inappropriate anti-tachycardia pacing (ATP). TS was consulted and confirmed the inappropriate therapy was not exhausted; however, the patient was hospitalized during this time. TS noted the R wave amplitude had previously decreased by remained normal. TS discussed reprogramming options but did not conclude on the best option. TS recommended a chest x ray to review system positioning. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50666608 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652732 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, 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-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• 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