INCEPTA ICDRecalls & reported problems across all models

We found 4 models of INCEPTA ICD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,746 adverse event reports in the FDA's MAUDE database, received between Jul 8, 2013 and Sep 30, 2026 — classified as 3 deaths, 1,322 injuries, 421 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (894 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 INCEPTA ICD problems

INCEPTA ICD models

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

• INCEPTA™ ICD E160

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths601 reports
• INCEPTA™ ICD E162

  Implantable pulse generator, pacemaker (non-CRT)
  570 reports
• INCEPTA™ ICD E163

  Implantable pulse generator, pacemaker (non-CRT)
  1 death339 reports
• INCEPTA™ ICD E161

  Implantable pulse generator, pacemaker (non-CRT)
  236 reports

Recent INCEPTA ICD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50955017 ↗
• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the health care professional (HCP) requested a review of reports for this implantable cardioverter defibrillator (ICD). The HCP suspected this ICD delivered anti-tachycardia pacing (ATP) and shocks for what appeared to be supraventricular tachycardia (SVT) with rapid ventricular response (RVR). Technical Services (TS) reviewed the data and noted the rhythm did appear to be SVT with RVR and recommended the patient follow up with cardiology. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50786653 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) had a magnet applied during a procedure. Following the procedure, Technical Services (TS) was consulted to evaluate device performance. TS reviewed the available data and confirmed that the device appeared to be functioning as programmed and expected. TS noted the presence of stored noise events that correlated with magnet application; however, no device-related issues or complications were identified. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783366 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602345 ↗
• InjurySep 4, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) visited the emergency room (ER) for evaluation after receiving shocks. Technical Services (TS) was called for consult review of device data. The device was interrogated however, due to device being in End of Life (EOL) battery status, the episodes were unable to be reviewed to determine shocks were appropriate or not because device does not store episodes when in EOL status. TS reviewed the stored daily threshold and impedance measurements trend reports which showed high out of range shock impedances measurements on the right ventricular (RV) lead that appeared to have been gradually increasing since 2018. Subsequently, later on, a generator replacement procedure was performed. This ICD was explanted due to normal battery depletion (NBD) and replaced with a new device successfully. The RV lead remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50601337 ↗
• InjurySep 3, 2026Inappropriate/Inadequate Shock/Stimulation; Data Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was at End of Life (EOL) and the patient was shocked five times. It appeared that the rate was controlled after the shocks were delivered. There was supposedly a note that device tachy mode was off and it was not determined whether the shocks were appropriate. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50588062 ↗
• InjuryAug 20, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  It was reported that this implantable cardioverter defibrillator (ICD) delivered five shocks and several rounds of anti-tachycardia pacing (ATP) for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) was contacted and after reviewing the data noted there was an irregular morphology present and that it appeared to become faster after a shock. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50360078 ↗
• MalfunctionAug 19, 2026Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was suspected of premature battery depletion (PBD) as the battery has depleted from 7 months down to reaching Elective Replacement Indicator state. The Boston Scientific Technical Services consultant evaluated the transmission data which demonstrated a charge time of 15.7 seconds, representing a secondary criterion for recommending a device replacement while the system continues to operate normally. Subsequently, this ICD was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50313817 ↗
• MalfunctionAug 18, 2026Signal Artifact/Noise; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291255 ↗
• MalfunctionAug 17, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287267 ↗
• InjuryAug 14, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate shocks and anti-tachycardia pacing (ATP) that induced ventricular tachycardia. Additionally, inappropriate continued to be delivered resulting in the rhythm accelerating from ventricular tachycardia to ventricular fibrillation. Technical Services (TS) was consulted and confirmed four bursts of ATP and two shocks; all being deemed inappropriate. TS additionally confirmed that the third burst of ATP accelerating the rhythm as previously mentioned. TS recommended increasing the ventricular tachycardia rate cutoff, rate controlling the patient, or turning on additional features for the ventricular tachycardia zone. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 50254250 ↗
• InjuryAug 5, 2026Insufficient Device Problem Information

  It was reported that the battery of this implantable cardioverter defibrillator (ICD) reached a completely depleted state beyond End of Life (EOL). Technical Services (TS) assessed the device and indicated that sinus bradycardia and ejection fraction (EF) of 20 percent were listed as the implant indications. To date, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150340 ↗
• InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) received two inappropriate shocks for what appeared to be atrial fibrillation with rapid ventricular response. The patient remained under continued monitoring. This device remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50091378 ↗
• MalfunctionJul 27, 2026Communication or Transmission Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036230 ↗
• MalfunctionJul 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829094 ↗

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