INCEPTA™ ICD E160Recalls & reported problems

Summary

The FDA's MAUDE database contains 601 adverse event reports that list this exact device (DI 00802526480751), received between Jul 8, 2013 and Sep 16, 2026 — classified as 2 deaths, 466 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (352 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 601 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829094 ↗
• InjuryJul 3, 2026Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED BATTERY CAPACITY DEPLETED (BCD) IN MARCH, BUT JUST 3 MONTHS PRIOR THE DEVICE SHOWED 1.5 YEARS REMAINING. TECHNICAL SERVICES (TS) REVIEWED AND FOUND THE CHARGE TIME (CT) WAS 15.6 SECONDS AND WHY THE EXPLANT INDICATOR WAS SHOWN. TS RECOMMENDED THE DEVICE BE REPLACED. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700636 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INTEGRATED CIRCUIT (IC) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THEIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25632671 ↗
• MalfunctionJun 24, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) DOCUMENTED THE OBSERVATION AND NOTED THAT THE PATIENT IS NONCOMPLIANT, AND THE SYSTEM HASN'T BEEN CHECKED FOR SOME TIME. TS ADDITIONALLY NOTED THAT THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO DEHYDRATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610828 ↗
• MalfunctionJun 22, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, INDICATING THE VOLTAGE IS 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 IRREGULARLY. DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THAT THE ROOT CAUSE OF THE CODE 1003 WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580105 ↗
• InjuryMay 21, 2026High impedance; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE ICD WAS UNABLE TO INTERROGATE DUE TO COMPLETE BATTERY DEPLETION. TECHNICAL SERVICES (TS) WAS CONSULTED AFTER THE FIELD REPRESENTATIVE CHECKED THE DEVICE AND CONFIRMED THAT THE BATTERY CAPACITY HAD BEEN DEPLETED DUE TO BEING IN SERVICE FOR APPROXIMATELY 13 YEARS. DURING THIS TIME, THE FIELD REPRESENTATIVE ALSO FOUND THAT SHOCK IMPEDANCE MEASUREMENTS WERE HIGH AND OUT OF RANGE. TS DOCUMENTED THIS AND RECOMMENDED REPLACING THE SYSTEM. THE ICD WAS EXPLANTED AND REPLACED. THE PATIENT IS EXPECTED TO FULLY RECOVER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD IS NO LONGER IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243971 ↗
• InjuryApr 29, 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 25032247 ↗
• InjuryApr 9, 2026Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) RECEIVED NOTIFICATION OF A FAILED REMOTE TRANSMISSION OF DATA DUE TO THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW BATTERY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WITH THE ICD VISITED THE HOSPITAL DUE TO INAPPROPRIATE SHOCK DELIVERY. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN END OF LIFE (EOL). SUBSEQUENTLY A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. THIS ICD WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND REPLACED WITH A NEW DEVICE SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS RETURNED TO FACILITY AND IS AWAITING ANALYSIS.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24837726 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO AN ADVISORY. THIS ICD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823730 ↗
• InjuryMar 31, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM RECORDED A CODE 1005, INDICATIVE OF HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING OPTIONS OR LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744573 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO THE PATIENT UNDERGOING RADIATION THERAPY. NO NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612887 ↗
• InjuryMar 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE 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 VOLTAGE WAS VALID AND THE BATTERY VOLTAGE RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. THIS ICD WAS EXPLANTED, REPLACED WITH DIFFERENT MODEL AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546565 ↗
• InjuryMar 2, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED TWO INAPPROPRIATE ELECTRIC SHOCKS. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND SUSPECTED THE SHOCKS WERE DELIVERED DUE TO OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI) NOISE. THE NOISE WAS UNABLE TO BE REPRODUCED WITH ISOMETRICS, AND THE PATIENT DIDN'T KNOW WHAT THEY WERE DOING AT THE TIME OF THE EPISODE. DEVICE THERAPY WAS NOT EXHAUSTED. IT WAS NOTED RIGHT VENTRICULAR (RV) LEAD MEASUREMENTS WERE ALL STABLE AND WITHIN NORMAL LIMITS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24487173 ↗
• InjuryFeb 24, 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 CONFIRMED THAT THIS DEVICE BATTERY VOLTAGE HAS RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436767 ↗
• MalfunctionFeb 18, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. PATIENT HAS A COMPATIBLE CONSULT AND IS USING THE CORRECT WANT. THE DEVICE HAS BEEN IN SERVICE FOR OVER 12 YEARS, PASSING BATTERY EXPECTATIONS. END OF LIFE (EOL) IS SUSPECTED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377428 ↗
• InjuryFeb 4, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SURGICALLY EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). THIS ICD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258054 ↗
• InjuryJan 20, 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 THAT THE LOW VOLTAGE FAULT WAS SET BY 12 MILLIVOLTS DROP IN BATTERY VOLTAGE WITHIN 3 DAYS AND PRIOR TO THIS THE BATTERY VOLTAGE WAS PROGRESSING AS EXPECTED. MOREOVER, THE DROP IN BATTERY VOLTAGE IS NOT CORRELATED WITH ANY OTHER SETTINGS OR DIAGNOSTICS WITHIN THIS DEVICE. FURTHERMORE, THIS DEVICE IS MALFUNCTIONING, AND A DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121717 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, 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-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-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-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