ENERGEN™ ICD E141Recalls & reported problems

Summary

The FDA's MAUDE database contains 368 adverse event reports that list this exact device (DI 00802526480720), received between Jul 7, 2014 and Sep 25, 2026 — classified as 284 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (226 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 368 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905816 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited oversensing of noisy signals for its right ventricular (RV) lead. Technical Services (TS) was consulted and reviewed stored data data. TS discussed stored data, with a decrease in impedance measurements for the RV lead. The impedance measurements were still within range. TS suspected a lead integrity issue based on the age of the RV lead. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755481 ↗
• InjuryJul 28, 2026High impedance

  It was reported that implantable cardioverter defibrillator (ICD) exhibited high out-of-range (OOR) shock impedance measurements on the right ventricular (RV) lead. Technical Services (TS) recommended considering RV lead replacement if the average shock impedance exceeds 150 ohms. Additional information was received indicating that a Defibrillation Threshold Test (DFT) was performed. Shock impedance measurements were found to be within range. This ICD was subsequently explanted, and another ICD was implanted to complete this procedure. This ICD has not been returned at this time. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057676 ↗
• InjuryJul 3, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND FOUR SHOCKS DUE TO NOISE OVERSENSING DURING A CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY. THE THERAPY WAS NOT NOTICED DURING THE SURGERY, BUT DURING A DEVICE INTERROGATION A COUPLE OF DAYS LATER WHICH WAS RECENTLY REVIEWED WITH TECHNICAL SERVICES (TS). THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25709175 ↗
• MalfunctionJul 1, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, INDICATIVE THAT THE VOLTAGE WAS TOO LOW FOR PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DEVICE DATA AND CONFIRMED THE BATTERY VOLTAGE HAD BEGUN DECREASING RAPIDLY, POTENTIALLY DUE TO AN INTERNAL BATTERY ISSUE. THE HEALTH CARE PROFESSIONAL (HCP) WAS ADVISED THAT PROMPT DEVICE REPLACEMENT WAS RECOMMENDED BECAUSE THE REMAINING BATTERY LONGEVITY COULD NOT BE ASSURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25685752 ↗
• MalfunctionJun 22, 2026Failure to Convert Rhythm; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A VENTRICULAR TACHYCARDIA (VT) ARRHYTHMIA. ANTI-TACHYCARDIA PACING WAS PROVIDED APPROPRIATELY BUT WAS INEFFECTIVE. A SHOCK WAS DELIVERED AND SLOWED THE VT ARRHYTHMIA BUT DID NOT TERMINATE IT. SUBSEQUENTLY, THE VT ARRHYTHMIA SPONTANEOUSLY SELF-TERMINATED. TECHNICAL SERVICES ADVISED THE AMPLITUDE IS QUITE LOW AND THERE WAS A COMPLETE MORPHOLOGY CHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586189 ↗
• MalfunctionJun 17, 2026Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCES. THERE WAS AN ALERT SHOWING THE LEAD IMPEDANCES VALUES WERE OUT OF RANGE AND THE DEVICE WAS CHECKED THAT SHOWED 21 OHMS AND THEN 0 OHMS. TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED THE PATIENT CONTINUE TO BE MONITORED AS NORMAL, AS WELL AS HEALTH CARE PROFESSIONAL (HCP) PERFORM TROUBLESHOOTING TO CONFIRM DEVICE ABILITY TO DELIVER SHOCK. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536374 ↗
• MalfunctionMay 22, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED RIGHT VENTRICULAR PACING INHIBITION OF APPROXIMATELY TWO SECONDS. TECHNICAL SERVICES (TS) ADVISED PACING INHIBITION WAS DUE TO OVERSENSING OF MYOPOTENTIAL NOISE. TS PROVIDED REPROGRAMMING RECOMMENDATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25260650 ↗
• MalfunctionMay 18, 2026Interrogation Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO INTERROGATE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THE PATIENT EXPERIENCED SHORTNESS OF BREATH (SOB) AND CHEST PAIN. THIS ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 25210910 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AFTER BEING APPROXIMATELY THIRTEEN YEARS IMPLANTED. NO PRODUCT PERFORMANCE ANOMALIES WERE REPORTED, AND NO FURTHER INFORMATION WAS PROVIDED. SUBSEQUENTLY, A NEW DEVICE WAS IMPLANTED. 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 25176415 ↗
• MalfunctionApr 13, 2026Premature Discharge of Battery; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR A POSSIBLE ATRIAL FIBRILLATION RHYTHM WITH RAPID VENTRICULAR RESPONSE (RVR). LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE ALSO NOTED. TECHNICAL SERVICES (TS) WAS CONSULTED AND INDICATED THAT SUCH MEASUREMENTS ARE OFTEN INDICATIVE OF AN INSULATION ISSUE. ADDITIONALLY, DELIVERY OF A SHOCK MAY ADVERSELY IMPACT THE PULSE GENERATOR. AS A RESULT, TS RECOMMENDED THAT THE PATIENT BE EVALUATED IN THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24867068 ↗
• MalfunctionFeb 3, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A FAULT CODE 1005 WHEN INTERROGATED. THE FAULT CODE INDICATES HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE AND REVIEWING THE DATA FOR THE LEFT VENTRICULAR (LV) LEAD CONFIRMED IT WAS OUT OF RANGE. THE LV LEAD IS A NON-BSC LEAD. THE DEVICE ALSO REACHED BATTERY CAPACITY DEPLETED (BCD). THIS ICD AND LV LEAD ARE PLANNED TO BE EXPLANTED AND REPLACED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254025 ↗
• InjuryDec 19, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND DELIVERED MORE THAN TWO INAPPROPRIATE SHOCKS DUE TO OVERSENSED NOISE ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED A LEAD EVALUATION. AT THIS TIME, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED, AND THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23849948 ↗
• InjuryDec 12, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW AN EVENT ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR INAPPROPRIATE THERAPY ON AN ATRIAL ARRYTHMIA. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND DETERMINED THAT THE DEVICE DELIVERED ONE ANTI-TACHYCARDIA PACING (ATP) BURST AND FOUR 41 JOULE SHOCKS FOR AN SUPRAVENTRICULAR TACHYCARDIA (SVT). THE RHYTHM WAS NOT TERMINATED AND TS PROVIDED REPROGRAMMING RECOMMENDATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23789474 ↗
• MalfunctionNov 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REQUIRES A DEFIBRILLATION THRESHOLD (DFT) TEST DUE TO THE DEVICE BEING PROGRAMMED IN REVERSE POLARITY, WITH THE REASON FOR THIS PROGRAMMING CHANGE REMAINING UNKNOWN. INITIAL IMPLANT RECORDS WERE UNAVAILABLE, WHICH LED TO UNCERTAINTY REGARDING ORIGINAL DEVICE SETTINGS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650670 ↗
• MalfunctionOct 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WENT OFF, AND PATIENT FELT AN INCIDENT HAPPEN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED PATIENT TO HEALTH CARE PROFESSIONAL (HCP). THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364024 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23363440 ↗
• MalfunctionOct 15, 2025High impedance; Failure to Read Input Signal; High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW INTRINSIC AMPLITUDE AND HIGH SHOCK IMPEDANCE OUT OF RANGE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED, THE RIGHT VENTRICULAR (RV) LEAD IS SUSPECTED TO HAVE BROKEN AND HAVING ISSUES, IS CURRENTLY IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296456 ↗
• InjurySep 9, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS SUSPECTED TO BE DEPLETING PREMATURELY WITH THE LONGEVITY DROP FROM 1.5 YEARS TO 3 MONTHS WITHIN A SPAN OF 5 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED NO LOW VOLTAGE FAULT HAS BEEN TRIGGERED BUT CONFIRMED THAT THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. THIS APPEARS CONSISTENT WITH CAPACITOR DEGRADATION DUE TO HYDROGEN GAS CONTENT IN THE SEALED PG ATMOSPHERE. TS RECOMMENDS REPLACEMENT WITHIN 90 DAYS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND A NEW ICD OF A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000125 ↗
• MalfunctionAug 19, 2025High impedance; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation; High impedance; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED AN INAPPROPRIATE SHOCK FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE SHOCK DID NOT CONVERT THE RHYTHM. THE SHOCK IMPEDANCE MEASUREMENT WAS GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) REVIEWED NOTING THIS WAS A GRADUAL RISE IN SHOCK IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. TS RECOMMENDED CONTINUING TO MONITOR. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22842797 ↗
• InjuryJul 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LOST WEIGHT. AS A RESULT, THIS ICD MIGRATED AND WAS PRESSING AGAINST HER SKIN. THE PATIENT HAD PAIN. SUBSEQUENTLY, THE ICD WAS EXPLANTED AND REPLACED WITH A SMALLER DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS ICD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: Pain

  MAUDE report 22554862 ↗
• InjuryJul 14, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DROPPED FROM 2 YEARS TO 23 MONTHS WITHIN THE SPAN OF 3 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ANALYSIS CONFIRMED THAT THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. THIS APPEARS CONSISTENT WITH CAPACITOR DEGRADATION DUE TO HYDROGEN GAS CONTENT IN THE SEALED PG ATMOSPHERE AND SUGGESTED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS DEVICE WAS EXPLANTED DUE TO PRODUCT PERFORMANCE ISSUE. A NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH A DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503083 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858803 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857020 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853452 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• 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-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-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• 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