PERCIVA™ ICD VR D400Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00802526587863), received between Jan 2, 2021 and Feb 6, 2026 — classified as 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “High impedance” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A JUMP IN RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCE MEASUREMENTS UP TO 1100 OHMS AND THEN WENT BACK DOWN TO THE 300'S. ISOMETRICS WERE PERFORMED, HOWEVER, NO NOISE WAS SEEN. TECHNICAL SERVICES (TS) INDICATED THIS MAY BE THE START OF SPRING CONTACT BEHAVIOR AND RECOMMENDED CONTINUOUS MONITORING AND PROGRAMMING CHANGES. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESOLUTION FOR THIS PATIENT IS CONTINUOUS MONITORING AND NO PROGRAMMING CHANGES WERE MADE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284576 ↗
• InjuryOct 8, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SIX ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). DURING THE DELIVERY OF THE SHOCK THERE WAS AN ALERT FOR LOW SHOCK IMPEDANCE WHEN ATTEMPTING TO DELIVER A SHOCK. THEN, THE ICD RECORDED TWO INSTANCES OF CODE 1006 INDICATIVE OF HIGH VOLTAGE DETECTED ON SHOCK LEAD DURING CHARGE ASSOCIATED TO THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. AFTERWARDS, THE DEVICE WAS UNABLE TO PROVIDE FURTHER SHOCKS. TECHNICAL SERVICES (TS) WAS CONSULTED AND AFTER REVIEWING THE DATA RECOMMENDED POSSIBLE TROUBLESHOOTING OPTIONS AND DEVICE REPLACEMENT. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23244713 ↗
• MalfunctionSep 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING OPTIONS AND DEFIBRILLATION THRESHOLD (DFT) TESTING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080488 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 WERE REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22765421 ↗
• MalfunctionJul 21, 2025High impedance; Off-Label Use; High impedance; Off-Label Use

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR ASSISTANCE WITH PROGRAMMING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) INFORMED THIS IS A NON-CONDITIONAL SYSTEM AS HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED AND PROGRAMMED THE ICD. AFTER THE MRI WAS PERFORMED, THIS ICD SYSTEM WAS REMOVED FROM THE MRI PROTECTION MODE, IT WAS CONFIRMED THAT ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND WAS FUNCTIONING AS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561389 ↗
• MalfunctionJun 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING SHOCK LEAD IMPEDANCE OUT OF RANGE ON THE RIGHT ATRIAL (RA) LEAD. RV LEAD NOW PROGRAMMED TO DISTAL COIL TO CAN. THRESHOLDS AND SENSING MEASUREMENTS REMAIN WITHIN NORMAL LIMITS. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338982 ↗
• MalfunctionJan 2, 2025High impedance; High impedance

  IT WAS REPORTED THAT A RED CALL DOCTOR ICON WAS OBSERVED ON THE COMMUNICATOR, INDICATIVE OF AN ALERT DUE TO HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056016 ↗
• InjuryNov 28, 2024Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT DURING A GENERATOR CHANGEOUT PROCEDURE TO THERAPY UPGRADE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WHEN IT WAS CONNECTED TO THIS DEVICE. AFTER THE POCKET WAS CLOSED, NOISE WAS EXHIBITED ON THE RV. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HEALTHCARE FACILITY AND THE RV WAS SURGICALLY ABANDONED AND REPLACED. THIS ICD WAS ALSO EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808207 ↗
• InjuryJul 17, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THREE DAYS POST IMPLANTATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE, THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY DELIVERY. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED REVIEW OF THE STORED EVENTS. UPON REVIEW OF THE PRESENTING ELECTROGRAM (EGM), TS WAS ABLE TO CONFIRM THAT THE FOUR BURSTS OF ATP THERAPY WERE INAPPROPRIATELY DELIVERED DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. TS ALSO NOTED THAT THERE WAS A SIGNAL ARTIFACT MONITOR (SAM) EPISODE RECORDED ON THE DEVICE, FURTHER REVIEW OF THE SAM EPISODE SHOWED THE RV LEAD EXHIBIT NOISE AND LOW OUT OF RANGE PACING IMPEDANCES WHICH LED TO THE RESPIRATORY SENSOR TO BE DISABLED. TS DISCUSSED WITH THE HCP PROGRAMMING OPTIONS. THE HCP STATED TO DISCUSS WITH THE PHYSICIAN ON PLANS TO TURN OFF RIGHT VENTRICULAR (RV) LEAD THERAPY AND PERFORM A VENOGRAM. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763673 ↗
• MalfunctionMar 6, 2024Signal Artifact/Noise; Over-Sensing; Data Problem; Signal Artifact/Noise; Over-Sensing; Data Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY STORED ARRHYTHMIA EPISODES AS A RESULT OF OVERSENSING ELECTROCAUTERY NOISE DUE TO A SURGICAL PROCEDURE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ALSO OBSERVED THE INTERNAL CLOCK OF THE DEVICE COULD BE OFF ACCOUNTING FOR THE TIME DISCREPANCY OF EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852372 ↗
• InjuryJan 9, 2024High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED A COMMANDED 41J SHOCK DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. AFTER THE ELECTRIC SHOCK WAS GIVEN, THE DEVICE DISPLAYED A CODE 1005, INDICATING AN OPEN CIRCUIT CONDITION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED A RIGHT VENTRICULAR (RV) LEAD REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Electric Shock

  MAUDE report 18480017 ↗
• InjuryOct 2, 2023High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1005, INDICATIVE OF SHOCKING INTO AN OPEN CIRCUIT. THIS DEVICE ALSO RECORDED HIGH OUT OF RANGE SHOCKING IMPEDANCE VALUES. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER REVIEW AND POSSIBLE REPLACEMENT OF THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD. INFORMATION FROM THE FIELD SUGGESTED THAT THE PHYSICIAN DISCUSSED SYSTEM REPLACEMENT WITH THE PATIENT, HOWEVER THEY CHOSE TO LEAVE THE EMERGENCY ROOM (ER) AGAINST MEDICAL ADVICE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850805 ↗
• InjuryJul 19, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS DECIDED TO TURN OFF THE THERAPY AND PROVIDE AN EXTERNAL DEFIBRILLATOR DEVICE. THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED DETAILING THAT THIS DEVICE WAS EXPLANTED AND REPLACED. THIS DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356952 ↗
• InjuryMar 31, 2023Failure to Convert Rhythm; Defective Device; Interrogation Problem; Failure to Convert Rhythm; Defective Device; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED CARDIAC ARREST. THE DEVICE DELIVERED AN ELECTRIC SHOCK, HOWEVER, IT WAS NOT SUCCESSFUL. THE PATIENT NEEDED TO BE EXTERNALLY RESUSCITATED AND WAS TREATED IN A HOSPITAL SETTING AND HOSPITALIZED IN THE ICU. IT WAS NOTED THIS DEVICE WAS UNABLE TO BE INTERROGATED. NO MAGNET RESPONSE WAS FOUND. DIFFERENT PROGRAMMERS WERE USED, HOWEVER, INTERROGATION OF THE DEVICE WAS NOT SUCCESSFUL. A DEVICE SYSTEM REVISION IS SCHEDULED IN THE NEAR FUTURE. ADDITIONAL INFORMATION WAS RECEIVED THAT A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND THIS DEVICE WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, THE NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WAS TESTED AND OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBTAINED. VISUAL INSPECTION CONFIRMED A LEAD FRACTURE. THIS LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Electric Shock

  MAUDE report 16659458 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INFECTION WITH SEPSIS AND WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14138650 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED THREE DAYS POST IMPLANT DUE TO A SUSPECTED FRACTURE OF THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD. A NEW DEVICE AND RV LEAD WERE IMPLANTED WITHOUT FURTHER INCIDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048895 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROTRUDING OUT OF THE CHEST. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion

  MAUDE report 13049314 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS A BREAST IMPLANTS THAT MADE THE DEVICE IMPLANTED MUCH HIGHER IN THE CLAVICULAR REGION AND WAS CAUSING SOME PAIN. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE CONFIRMED THAT A REVISION WAS MADE. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 12701723 ↗
• MalfunctionJan 2, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS SYSTEM EXHIBITED JUMPY AND VARYING PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL. A REVIEW OF THE DEVICE DATA IDENTIFIED TWO RED ALERTS HAD BEEN GENERATED DUE TO THE MEASUREMENTS EXCEEDING 2000 OHMS. THE PATIENT'S SYSTEM CONSISTS OF THIS BOSTON SCIENTIFIC IMPLANTABLE PULSE GENERATOR (IPG) AND A COMPETITIVE RV LEAD. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED POTENTIAL REASONS FOR THE CLINICAL OBSERVATIONS AND TROUBLESHOOTING TECHNIQUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11104870 ↗

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-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