RESONATE™ HF ICD DR D533Recalls & reported problems

Summary

The FDA's MAUDE database contains 462 adverse event reports that list this exact device (DI 00802526588310), received between Jul 20, 2022 and Sep 28, 2026 — classified as 2 deaths, 268 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (111 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 462 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 50919608 ↗
• InjurySep 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered two anti-tachycardia pacing (ATP) and three shocks for what appeared to be a one to one rhythm. Technical Services (TS) recommended reprogramming options. The device was reprogrammed and functioning as intended. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50914730 ↗
• MalfunctionSep 18, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50822447 ↗
• MalfunctionSep 18, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high out of range pacing impedance measurements greater than 3000 Ohms in the right atrial (RA) channel. It was also observed that there was a Signal Artifact Monitor (SAM) event due to oversensed non-physiologic noise. Atrial Tachy Response (ATR) events were also recorded. Technical Services (TS) was contacted and recommended evaluating in office. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819961 ↗
• MalfunctionSep 14, 2026Failure to Read Input Signal; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764183 ↗
• MalfunctionSep 14, 2026Under-Sensing

  It was reported that this pacemaker exhibited undersensing for its right atrial (RA) lead. Technical Services (TS) was consulted and discussed stored data, with reprogramming of the RA sensitivity recommended. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756127 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited oversensing and noisy signals. Technical Services (TS) was consulted and noted the patient has a left ventricular assist device which may have contributed with electromagnetic interference. TS was unable to review data at this time. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714635 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50679080 ↗
• InjurySep 8, 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. This ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50677208 ↗
• MalfunctionSep 7, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658542 ↗
• MalfunctionSep 4, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602094 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602032 ↗
• InjurySep 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50600898 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50599871 ↗
• InjuryAug 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) received inappropriate anti-tachycardia pacing (ATP) and five shocks for an apparent episode of atrial arrhythmia with rapid ventricular response (RVR) while stepping out of the shower with no symptoms. Therapy was exhausted. Technical Services (TS) was consulted and recommended the patient follow-up with their cardiologist. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50421706 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise; Low impedance; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370200 ↗
• MalfunctionAug 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370198 ↗
• 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 50319153 ↗
• InjuryAug 18, 2026Defibrillation/Stimulation Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) experienced a syncopal episode during a ventricular fibrillation (VF) event. Appropriate anti-tachycardia pacing (ATP) was delivered for ventricular tachycardia (VT); however, the rhythm was accelerated into VF. Technical Services (TS) was contacted and reviewed the information available. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 50290583 ↗
• InjuryAug 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 50284743 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) and both leads were explanted with less than a year of use due to an infection. A new subcutaneous implantable cardioverter defibrillator (S-ICD) system was implanted and remains in service. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50280341 ↗
• InjuryAug 13, 2026Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) experienced ventricular tachycardia (VT) for which the implanted defibrillator delivered six appropriate shocks; however, the arrhythmia was not terminated by device therapy. The patient reported that intravenous amiodarone was subsequently administered, resulting in successful conversion of the arrhythmia. Additional information indicated that post-event defibrillation threshold (DFT) testing demonstrated successful conversion with the first shock. The patient contacted Technical Services (TS) to inquire why the delivered therapies were unsuccessful and was advised that multiple factors may influence therapy efficacy. The patient was referred for further evaluation. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50244666 ↗
• InjuryAug 13, 2026Defibrillation/Stimulation Problem

  It was reported that this implantable cardioverter defibrillator (ICD) did not deliver shock as therapy for a patients ventricular tachycardia (VT). The device settings were adjusted afterwards, with the therapy conditional zone lowered. Technical Services (TS) was consulted and discussed how they should contact their physician to further discuss their device settings. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243517 ↗
• InjuryAug 12, 2026Signal Artifact/Noise

  It was reported that this implantable cardioverter defibrillator (ICD) recorded ventricular episodes presented in the logbook. The Boston Scientific Technical Services consultant noted noisy signals on both channel which was suspected to be electromagnetic interference and recommended to confirm if the patient had any procedures or surgery performed. As of this time, this ICD remains in service. No adverse patient effects were reported.Additional information indicated that the noisy signals were from the cauterization when the patient was having a surgery. There was no reprogramming performed. Subsequently, this ICD was explanted and replaced with a different model. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228408 ↗
• InjuryAug 11, 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 50207587 ↗

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