PERCIVA ICD VRRecalls & reported problems across all models

We found 2 models of PERCIVA ICD VR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2018 and Sep 28, 2026 — classified as 2 deaths, 124 injuries, 36 malfunctions.

The most frequently reported specific device problem is “High impedance” (31 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PERCIVA ICD VR problems

PERCIVA ICD VR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PERCIVA™ ICD VR D412

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths143 reports
• PERCIVA™ ICD VR D400

  Implantable cardioverter defibrillator (non-CRT)
  19 reports

Recent PERCIVA ICD VR adverse event reports

The 15 most recent reports across all models, 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 ↗

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