PERCIVA™ ICD VR D412Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00802526587924), received between Aug 2, 2018 and Sep 28, 2026 — classified as 2 deaths, 112 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (23 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 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• InjurySep 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 50917544 ↗
• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potentially inappropriate anti-tachycardia pacing (ATP) and shocks. The device is single chamber so it was unclear if the arrhythmia is atrial-driven. Technical Services (TS) discussed possible programming options with the patients physician. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50783682 ↗
• InjurySep 16, 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 50783301 ↗
• InjuryAug 11, 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. Reportedly, the patient went to the emergency room due to infected incision site that was probably related to the MRSA (methicillin-resistant Staphylococcus aureus). No adverse patient effects were reported. The ICD was explanted.

  Patient problems: Bacterial Infection

  MAUDE report 50204419 ↗
• MalfunctionAug 6, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160871 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to a large hematoma and visible infection at the device implant incision/wound site. No additional adverse patient effects were reported. This ICD was not returned for analysis.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 50144369 ↗
• InjuryJul 30, 2026Failure to Convert Rhythm

  It was reported that this implantable cardioverter defibrillator (ICD) delivered shock therapy but did not convert. There was a syncopal episode that correlates with the arrythmia. The rhythm was eventually converted; spontaneous conversion is correlated. There was a Technical Services (TS) was consulted and noted the device appeared to be functioning as programmed. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: Syncope/Fainting

  MAUDE report 50090992 ↗
• MalfunctionJul 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071978 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE FIELD CLINICAL REPRESENTATIVE THAT THE PATIENT BELIEVED THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT PERFORMING AS INTENDED. IN ADDITION, THE PATIENT REPORTEDLY REQUIRED FREQUENT EMERGENCY ROOM VISITS FOR CARDIAC SITUATIONS. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742880 ↗
• InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ERODED THROUGH THE SKIN OF THE PATIENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REMOVE THE SYSTEM. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pocket Erosion

  MAUDE report 25704228 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED DEVICE HAD GONE OFF THAT WOKE HIM FROM SLEEP. AS OF THIS TIME DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678071 ↗
• MalfunctionJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED DIZZINESS AND A FALL IN THEIR DRIVEWAY. TECHNICAL SERVICES (TS) WAS CONSULTED BY THE ADVOCATE FOR THE PATIENT AND REFERRED THEM TO THEIR FOLLOWING CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Fall

  MAUDE report 25471141 ↗
• InjuryJun 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25464011 ↗
• InjuryJun 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS DEVICE WAS EXPLANTED AND A NEW ICD OF THE SAME MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439091 ↗
• MalfunctionJun 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DUE TO REPORTED SHOCK. UPON REVIEW, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED FOR SUPRAVENTRICULAR TACHYCARDIA (SVT). AFTERWARDS, A SHOCK WAS DELIVERED AND CONVERTED THE RHYTHM. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS SINGLE CHAMBER ICD SYSTEM WAS EXPLANTED AND UPGRADED TO A DUAL CHAMBER ICD SYSTEM WITH A RIGHT ATRIAL (RA) LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25418325 ↗
• InjuryJun 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 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 25416524 ↗
• InjuryJun 2, 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 EROSION AND INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 25363991 ↗
• InjuryMay 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION OBTAINED, THE DEVICE WAS EXPLANTED DUE TO MICROPERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 25334379 ↗
• InjuryMay 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 25322650 ↗
• InjuryApr 15, 2026High impedance; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES WITH VALUES GREATER THAN 200 OHMS IN THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED REPROGRAMMING GUIDANCE. AFTER REPROGRAMMING, A TREND OF LOW WITHIN RANGE SHOCK IMPEDANCES WERE OBSERVED. FURTHER EVALUATION WAS RECOMMENDED. SUBSEQUENTLY, THIS ICD WAS REPORTED TO BE EXPLANTED AND REPLACED. OTHER THAN THE INTERVENTION NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886913 ↗
• MalfunctionMar 25, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED RED ALERTS DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690878 ↗
• MalfunctionMar 17, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF 134 OHMS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624056 ↗
• InjuryMar 5, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THAT THE BATTERY VOLTAGE WAS DROPPING IN AN IRREGULAR FASHION. THIS COULD LIKELY BE RELATED TO AN INTERNAL ELECTRICAL SHORT OF THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515521 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24373938 ↗
• InjuryFeb 12, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) AFTER EXPERIENCING SHOCKS/PULSES WHILE IN THE SHOWER. PATIENT SYMPTOMS INCLUDED DISCOMFORT AND NAUSEA. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A PROGRAMMER WAS NOT AVAILABLE FOR INTERROGATION, AND A LOCAL FIELD REPRESENTATIVE WAS PAGED FOR FURTHER ASSISTANCE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS, AND THE INTRINSIC AMPLITUDE HAD CHANGED FROM 25MV (AT IMPLANT) TO 1.5 MV. THERE WAS NO ACTIVITY ON THE SHOCK CHANNEL, AND NOISE WAS OBSERVED IN STORED EVENTS. IT WAS RECOMMENDED THAT THE PATIENT SEE THE ELECTROPHYSIOLOGIST AND GET X-RAYS TO CONFIRM LEAD POSITION. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Nausea; Shock from Patient Lead(s)

  MAUDE report 24329414 ↗

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-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-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