PERCIVA™ ICD DR D413Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 00802526587955), received between Jul 2, 2018 and Sep 30, 2026 — classified as 3 deaths, 148 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (39 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate anti-tachycardia pacing (ATP) and an inappropriate shock. Technical Services (TS) was consulted and found the device was correctly inhibiting until the sustained rate duration was triggered. TS noted that the correlation percentage was inconsistent and low. TS recommended turning off sustained rate duration and program a lower correlation percentage. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50947548 ↗
• MalfunctionSep 30, 2026Pacing Problem; Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited undersensing on the right atrial (RA) lead. The true R waves were blanked and pacing was delivered. Technical Services (TS) recommended reprograming for this device. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947388 ↗
• MalfunctionSep 28, 2026Interrogation Problem

  It was reported that the health care professional (HCP) had difficulties interrogating this implantable cardioverter defibrillator (ICD). Technical Services (TS) confirmed the patient had a compatible device and that the HCP was using the correct wand. The HCP mentioned they had power cycled the programmed. TS discussed going into programmer mode and then interrogating the device; the HCP was still unable to read the device. TS suspected the wand was no longer functional due to the wires in the wand. Additional information was requested but unable to be obtained at this time. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913899 ↗
• InjurySep 24, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited shock impedance measurements high out of range on the right ventricular (RV) channel. Subsequently, this device was explanted and replaced. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889334 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate shocks for atrial tachycardia. The patient experienced several arrythmias that all appeared to be atrial driven with a total of 30 shocks delivered. The patient and their system will continue to be monitored. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50884315 ↗
• MalfunctionSep 17, 2026Device Alarm System

  It was reported that the patient with this implantable cardioverter-defibrillator (ICD) stated that the device was beeping. The patient presented to the clinic, where evaluation revealed that the battery was depleted. The clinic subsequently addressed the battery anomaly. To date, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798091 ↗
• MalfunctionSep 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658332 ↗
• InjuryAug 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 was no additional adverse patient effects reported. The ICD was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50326206 ↗
• MalfunctionAug 13, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50244678 ↗
• MalfunctionJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 50077588 ↗
• InjuryJul 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) received anti-tachycardia pacing (ATP) and multiple shocks for episodes of supraventricular tachycardia (SVT). Therapy was exhausted. Technical Services (TS) discussed the episode with the health care professional (HCP) and the cardiologist, which then followed up with the patient. The device appears to be functioning as programmed, and remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50061594 ↗
• InjuryJul 7, 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 25741921 ↗
• InjuryJul 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. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25728045 ↗
• InjuryJul 1, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN ATRIAL TACHYCARDIA WITH 1:1 CONDUCTION THAT ACCELERATED INTO THE VENTRICULAR TACHYCARDIA (VT) ZONE. THE DEVICE CLASSIFIED THE RHYTHM AS VENTRICULAR TACHYCARDIA, RESULTING IN THREE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPIES FOLLOWED BY FOUR INAPPROPRIATE SHOCKS. THE RHYTHM REMAINED ATRIAL TACHYCARDIA WITH 1:1 CONDUCTION. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25682411 ↗
• InjuryJun 23, 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 25595528 ↗
• MalfunctionJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SUSPECTED OF NOT WORKING. THE PATIENT ADVOCATE CONTACTED TECHNICAL SERVICES (TS) WITH QUESTIONS REGARDING DEVICE MANAGEMENT DURING A PLANNED RADIOFREQUENCY (RF) ABLATION PROCEDURE. TS REVIEWED MAGNET APPLICATION AND CAUTERY MODE AND ADVISED THAT THE ANESTHESIA TEAM CONTACT TS FOR FURTHER DISCUSSION REGARDING DEVICE MANAGEMENT DURING THE PROCEDURE. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25578315 ↗
• InjuryJun 10, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM STORED TWO VENTRICULAR EPISODES WERE APPROPRIATE TACHY THERAPY WAS DELIVERED AND THERAPY WAS EXHAUSTED DUE TO TRUE VENTRICULAR TACHYCARDIA (VT). THERAPY INTERRUPTED THE RHYTHM, HOWEVER THE ARRHYTHMIA WAS INCESSANT AND CONTINUOUS. PROGRAMMING OPTIMIZATION WAS ADVISED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465733 ↗
• MalfunctionJun 8, 2026Failure to Read Input Signal; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL UNDERSENSING ON THE PRESENTING ELECTROGRAM (EGM). TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND NOTED THAT THE ATRIAL SENSITIVITY WAS PROGRAMMED TO 0.2 MV WITH A MEASURED P-WAVE AMPLITUDE OF APPROXIMATELY 0.2 MV, THAT COULD POTENTIALLY CAUSED THE UNDERSENSING. ADDITIONALLY, HIGH CAPTURE THRESHOLDS WERE NOTED ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD MEASURED AT APPROXIMATELY 4.0 V. TS PROVIDED REPROGRAMMING OPTIONS FOR ATRIAL SENSITIVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437410 ↗
• InjuryJun 2, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED HIGH IMPEDANCE MEASUREMENTS IN ALL CHANNELS DATING PRIOR TO THE EXPLANT DATE. TECHNICAL SERVICES (TS) WAS CONTACTED AND UPON REVIEWING THE DATA, NOTED THAT THIS ICD WAS TAKEN OUT OF SHIPPING MODE DAYS PRIOR TO IMPLANT WHICH IS CONSISTENT WITH HIGH IMPEDANCE MEASUREMENTS SINCE THERE WERE NO LEADS ATTACHED TO THE ICD YET. AFTER IMPLANTING, ALL MEASUREMENTS RECORDED WERE WITHIN NORMAL LIMITS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 25368108 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A POCKET REVISION TO EVACUATE BLOOD CLOTS DUE TO POCKET HEMATOMA AFTER INSERTION. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 25357384 ↗
• MalfunctionMay 25, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270968 ↗
• InjuryMay 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25177219 ↗
• InjuryApr 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. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24911941 ↗
• InjuryApr 16, 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 24899184 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD HEMATOMA. THIS DEVICE WAS SURGICALLY REVISED TO REMOVE POCKET HEMATOMA AND THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INDICATES THAT THIS ICD WAS A PART OF A FULL SYSTEM EXTRACTION DUE TO INFECTION AND A NEW ICD OF THE SAME MODEL WAS PLACED. THIS DEVICE WAS RETAINED BY THE CUSTOMER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 24725606 ↗

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