RESONATE™ HF ICD VR D532Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00802526588280), received between Jul 4, 2022 and Sep 29, 2026 — classified as 108 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (37 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 150 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Over-Sensing; Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 50941358 ↗
• MalfunctionSep 29, 2026High impedance; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934817 ↗
• InjurySep 17, 2026High impedance

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) and right ventricular (RV) lead experienced a syncopal episode. Technical Services (TS) was consulted and reviewed the available information, noting that shock impedance measurements had been trending upward while remaining within normal limits. Subsequently, the patient developed an infection that necessitated extraction of the ICD and RV lead. These products have not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Syncope/Fainting; Unspecified Infection

  MAUDE report 50798180 ↗
• InjurySep 11, 2026Use of Device Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) went to the emergency room (ER) for chest pain. The patient claimed the emergency medical technician (EMT) said the electrocardiogram (EKG) showed he was having a heart attack, but the medical flight said the EKG didn't show that. The patient believed their chest pain was caused by gas but was told it could've been his device. The patient claimed they were not given results on Latitude NXT. Technical Services (TS) discussed that the clinician can access the Latitude transmission and advised the patient to follow up. The patient also claimed they were feeling pain at the device site since implant that felt like a pinching sensation. The patient stated when they put their arms behind their back, the pain went away. The patient also claimed that the physician left behind gauze at implant, and the patient needed additional surgery to remove the gauze. TS advised the patient to follow up with their physician for device and physician concerns. The patient stated they had a follow up with their primary clinician the day of the call. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: Chest Pain; Implant Pain

  MAUDE report 50733661 ↗
• 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 was no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50717460 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698708 ↗
• MalfunctionSep 9, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695667 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50652890 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50600109 ↗
• InjurySep 3, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) was part of the system revision due to infection. No additional adverse patient effects were reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50588063 ↗
• InjurySep 2, 2026Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570619 ↗
• MalfunctionSep 2, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565653 ↗
• InjuryAug 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered two bursts of anti-tachycardia pacing (ATP) and five shocks as inappropriate therapy for a suspected supraventricular tachycardia (SVT). Technical Services (TS) was consulted and discussed stored data as well as programming options, with the device programmed settings adjusted and the patient been prescribed rate control medications. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50420735 ↗
• InjuryAug 14, 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 in the implant site. The patient is on the heavy side and has large breast tissue which the physician believed to have pulled on the device incision site leading to 2 small areas opening up in the incision causing the infection. The pocket site appeared to have puss and was then cultured. The patient has a chlorhexidine allergy that was discovered while administering an antibiotic flush that had some chlorhexidine in it. There was no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50263468 ↗
• MalfunctionAug 14, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263463 ↗
• MalfunctionAug 7, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177973 ↗
• InjuryAug 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered one burst of anti-tachycardia pacing (ATP) and six shocks as inappropriate therapy for the patients supraventricular tachycardia (SVT). Technical Services (TS) was consulted and discussed stored data as well as available programming options based on available data. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50116640 ↗
• InjuryJul 28, 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 50060360 ↗
• MalfunctionJul 6, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ABOVE 200 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND TROUBLESHOOTING OPTIONS WERE RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719238 ↗
• InjuryJun 24, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 5 BURSTS OF ANTI-TACHYCARDIA PACING (ATP) DURING A SLOW VENTRICULAR TACHYCARDIA (VT) EPISODE. HOWEVER, THE RHYTHM WAS NOT ABLE TO BE CONVERTED AND THE THERAPY WAS EXHAUSTED. THE RHYTHM REMAINED SLOW; THEREFORE, NO ADDITIONAL THERAPY WAS PROVIDED BASED ON PROGRAMMING. IT WAS DETERMINED THAT THE DEVICE OPERATED APPROPRIATELY AND THE PATIENT WAS SCHEDULED FOR A VENTRICULAR TACHYCARDIA (VT) ABLATION. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611978 ↗
• InjuryJun 1, 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 25353902 ↗
• InjuryMay 14, 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 25176405 ↗
• InjuryMay 6, 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 25095742 ↗
• InjuryMay 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 BLOOD INFECTION. THE PATIENT HAD CHRONIC COUGH AND INFECTION WAS FOUND ATTACHED TO A LEAKY VALVE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25084099 ↗
• MalfunctionApr 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE ELECTRIC SHOCK. IT WAS CONFIRMED THAT THIS ICD WAS WORKING AS PROGRAMMED. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25022115 ↗

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-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-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-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-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