PERCIVA ICD DRRecalls & reported problems across all models

We found 2 models of PERCIVA ICD DR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 297 adverse event reports in the FDA's MAUDE database, received between Jul 2, 2018 and Sep 30, 2026 — classified as 3 deaths, 171 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (48 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 DR problems

PERCIVA ICD DR models

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

• PERCIVA™ ICD DR D413

  Implantable cardioverter defibrillator (non-CRT)
  3 deaths248 reports
• PERCIVA™ ICD DR D401

  Implantable cardioverter defibrillator (non-CRT)
  49 reports

Recent PERCIVA ICD DR adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 28, 2026High impedance; Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060793 ↗
• 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 ↗

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