RESONATE™ EL ICD VR D432Recalls & reported problems

Summary

The FDA's MAUDE database contains 439 adverse event reports that list this exact device (DI 00802526588044), received between Oct 18, 2018 and Sep 18, 2026 — classified as 7 deaths, 297 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (90 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 439 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829865 ↗
• MalfunctionSep 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698712 ↗
• MalfunctionSep 4, 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 dropped precipitously below 2200 millivolts which was likely due to this device not capable of delivering high voltage therapy and was also likely to enter storage mode disabling brady therapy. 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 50602457 ↗
• MalfunctionSep 4, 2026Low impedance

  It was reported that this patient was scheduled for an implantable cardioverter defibrillator (ICD) to cardiac resynchronization therapy defibrillator (CRT-D) upgrade procedure with conduction system pacing (CSP) lead placement. CSP lead placement was attempted, but there was no capture. The LV lead was removed, and the original ICD was placed back into the pocket. Prior to the procedure, in-range shock impedances were noted. After placing the original ICD back into the pocket, a low out-of-range shock impedance measurement of 0 Ohms was observed. Visual inspection of the chronic right ventricular (RV) defibrillation lead confirmed there was no visible damage, and the physician opted to connect the chronic RV lead with the new ICD. A low out-of-range shock impedance measurement of 0 Ohms persisted with this new ICD, and Technical Services (TS) was consulted for troubleshooting. TS recommended turning off the electrocautery grounding pad, which resolved the out-of-range shock impedance measurement. The procedure was completed, and this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600901 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) had an infection. A revision was performed and the ICD along with the right ventricular (RV) lead were explanted. No additional adverse patient effects were reported. The device was not returned for analysis.

  Patient problems: Unspecified Infection

  MAUDE report 50287290 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Implantable cardioverter defibrillator (ICD) and the right ventricular (RV) lead were electrically abandoned and a subcutaneous implantable cardioverter defibrillator (S-ICD) system was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pocket Erosion; Unspecified Infection

  MAUDE report 50240149 ↗
• MalfunctionAug 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216530 ↗
• MalfunctionJul 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50050948 ↗
• InjuryJul 21, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potentially inappropriate anti-tachycardia pacing (ATP) and shocks for an atrial arrhythmia with rapid ventricular response (RVR). Additionally, a shock was found to potentially accelerate the rhythm further into ventricular fibrillation (VF). Therapy was exhausted and the rhythm was found to have slowed down to the monitor only zone. It was hard for Technical Services (TS) to determine if the device therapy caused the acceleration in heart rate or if it was due to the patient condition but could not rule out the shock delivered changed the rhythm. This ICD remains in service. No additional adverse patient effects were reported.

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

  MAUDE report 25896722 ↗
• MalfunctionJul 17, 2026Failure to Capture; Pacing Problem; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HEART RATE OF 30 BEATS PER MINUTE (BPM). TECHNICAL SERVICES (TS) WAS CONSULTED AND , UPON DATA REVIEW , DISCUSSED THAT THE HEART RATE WAS BELOW THE DEVICE'S LOWER RATE LIMIT. INTERMITTENT HIGH CAPTURE THRESHOLDS WERE NOTED, AND THE RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) TEST DETECTED AS GREATER THAN PROGRAMMED AMPLITUDE OR SUSPENDED. FURTHER RV LEAD EVALUATION WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25860567 ↗
• MalfunctionJul 15, 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. IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS REVEALED THE POWER CONSUMPTION WAS GRADUALLY INCREASING. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829222 ↗
• InjuryJul 10, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  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 RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION. 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 25786547 ↗
• InjuryJul 3, 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 25703183 ↗
• MalfunctionJul 3, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING AND UNDERSENSING. TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND FOUND FUNCTIONAL UNDERSENSING DUE TO PATIENT CONDITION. TS RECOMMENDED POTENTIAL PROGRAMMING CHANGES FOR THIS ICD. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700644 ↗
• MalfunctionJun 30, 2026Signal Artifact/Noise; Off-Label Use; Under-Sensing

  IT WAS REPORTED THAT DURING A FOLLOW UP VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTING ELECTROGRAM (EGM). IT WAS NOTED THAT THE PATIENT RECENTLY WAS IMPLANTED WITH A CONCOMITANT DEVICE AND THERE APPEARS TO BE SOME INTERACTION NOTED. UPON REVIEW, THE STORED EGMS SHOWED A VENTRICULAR ARRHYTHMIA WAS NOTED BUT THE CONCOMITANT DEVICE PLUSES ARE ONLY DETECTING EVERY OTHER BEAT. DUE TO DEVICE PROGRAMMING AND THE AMPLITUDE OF THE ADDITIONAL DEVICE PULSES, EVERY OTHER VT BEAT IS BEING INTERMITTENTLY UNDERSENSED. TS PROVIDED PROGRAMMING OPTIMIZATION RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673573 ↗
• MalfunctionMay 5, 2026Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. ALSO, PATIENTS BEEPER IS BEEPING. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088195 ↗
• MalfunctionApr 30, 2026Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) DUE TO OVERSENSING OF WIDE COMPLEXES. THE PATIENT APPEARED TO BE IN A SLOW VENTRICULAR TACHYCARDIA (VT) WITH A RATE IN THE 100 TO 110 BEATS PER MINUTE (BPM) RANGE. THE SHOCK CHANNEL SHOWED WIDE COMPLEXES, AND PRESENTING STRIPS APPEARED NARROW AND UPRIGHT. A MONITOR ZONE WAS PROGRAMMED TO 110 BPM FOR CONTINUED MONITORING TO DETERMINE WHETHER THIS BEHAVIOR WAS A COMMON OCCURRENCE. THE PHYSICIAN PLANNED TO BRING THE PATIENT IN FOR AN OFFICE VISIT AT A LATER DATE FOR FURHTER EVALUATION. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038794 ↗
• InjuryApr 29, 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 25033859 ↗
• InjuryApr 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 24831794 ↗
• InjuryMar 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE SHOCKS DUE TO INTERMITTENT T WAVE OVERSENSING. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR PROGRAMMING ASSISTANCE. TS PROVIDED PROGRAMMING OPTIMIZATION RECOMMENDATIONS. AT THIS TIME, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE. SUBSEQUENT ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT AN EXPLANT PROCEDURE WAS PERFORMED. THIS ICD WAS EXPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS RETAINED BY THE HOSPITAL.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24736576 ↗
• InjuryMar 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. REPORTEDLY, THE PATIENT HAD FOOT INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24715409 ↗
• InjuryMar 19, 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 24641776 ↗
• MalfunctionMar 17, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPEDANCES WERE MOSTLY STEADY WITH SPIKES THAT WENT OVER 125 OHMS OCCASIONALLY. THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618796 ↗
• MalfunctionFeb 27, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED ASSISTANCE. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471033 ↗
• InjuryFeb 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED EPISODES INQUIRING ABOUT THE NUMBER OF SHOCKS DEVICE DELIVERED. THE ELECTROGRAM (EGM) SHOWED PATIENT APPEARED TO BE IN A SUPRAVENTRICULAR TACHYCARDIA (SVT) THAT WAS MOSTLY CORRELATED. THE DEVICE HAD DELIVERED 5 BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND 6 SHOCKS. THERAPY WAS EXHAUSTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24354027 ↗

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-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