INOGEN™ EL ICD DR D143Recalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00802526534263), received between Apr 21, 2016 and Sep 29, 2026 — classified as 151 injuries, 146 malfunctions.

The most frequently reported specific device problem is “High impedance” (123 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 297 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) for a consult review of the implantable cardioverter defibrillator (ICD) stored episode due to concerns of oversensing noise. The HCP stated that the episode occurred while the patient was exercising. Upon review, the presenting electrogram (EGM) showed oversensed noise that appears to be inhibiting pacing. Its noted patient is not pacing dependent. TS also noted a drop in right ventricular (RV) lead pacing impedance from 900 to 600ohms which are still considered to be within normal limits (WNL). . TS recommended an in clinic visit for isometric evaluation of the lead. Subsequently, a revision procedure was performed. The ICD was explanted and replaced with a new device. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935349 ↗
• MalfunctionSep 9, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700311 ↗
• MalfunctionSep 9, 2026Over-Sensing; Failure to Read Input Signal

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited far-field p-wave oversensing on the right ventricular (RV) channel. It was also noted there was an RV amplitude that was out of range. Technical Services (TS) reviewed the data and noted the R-wave was marked as ventricular fibrillation (VF) and there was no blanking for the atrial sense. TS recommended performing a defibrillation threshold (DFT) test and suggested reprogramming options. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690106 ↗
• InjurySep 4, 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 unknown circumstances. The replacement was successfully performed and a new device was implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned to the laboratory for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602066 ↗
• MalfunctionAug 12, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229896 ↗
• InjuryJul 9, 2026Pacing Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF TACHYCARDIA EPISODES ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TECHNICAL SERVICES (TS) REVIEWED THE STORED EPISODES AND NOTED THE EPISODES APPEARED ATRIAL DRIVEN WITH 1:1 RHYTHM THAT WERE SUCCESSFULLY TERMINATED WITH ANTI-TACHYCARDIA PACING (ATP). TS COULD NOT RULE OUT THAT PACING CONFIGURATION INITIATED THE ATRIAL ARRYTHMIA AND REPROGRAMMING OPTIONS WERE DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Tachycardia

  MAUDE report 25771539 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR PHYSICIAN FOR FURTHER EVALUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Syncope/Fainting

  MAUDE report 25725382 ↗
• InjuryJul 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED SEVERAL EPISODES IN WHICH INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND ELECTRIC SHOCKS WERE DELIVERED FOR SINUS TACHYCARDIA. THE ATP DID NOT WORK, AND SHOCK SLOWED RATE AT ONE OF THE EPISODES. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25713971 ↗
• MalfunctionJun 18, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. NO NOISE WAS OBSERVED. FURTHER EVALUATION WAS RECOMMENDED BY TECHNICAL SERVICES (TS). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25556304 ↗
• MalfunctionMay 14, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. THE COMPANY REPRESENTATIVE INFORMED THE PATIENT ABOUT THE CONDITION OF HER CURRENT ICD SYSTEM AND DISCUSSED THE AVAILABLE OPTIONS, INCLUDING EXTRACTION AND REPLACEMENT. A CLINICAL FOLLOW UP WAS SCHEDULED IN SIX MONTHS TO EVALUATE AND DETERMINE THE NEXT STEPS. AT THIS TIME, THE ICD AND RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178956 ↗
• MalfunctionApr 15, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS ON THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) DISCUSSED CHANGING THE ALERT PROGRAMMING AND CONTINUING TO MONITOR. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887482 ↗
• InjuryApr 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24809028 ↗
• InjuryMar 30, 2026Off-Label Use; Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Use of Device Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS COMMANDED TO DELIVER ONE BURST OF ANTI-TACHYCARDIA PACING (ATP) FOR AN ATRIAL FLUTTER. THIS INDUCED A VENTRICULAR FIBRILLATION (VF) AND THEN A COMMANDED SHOCK WAS DELIVERED. SUBSEQUENTLY THE PHYSICIAN PRESSED THE ABORT FUNCTION BUTTON THINKING IT WAS MEANT TO DELIVER A SHOCK. LASTLY, A COMMANDED SHOCK WAS DELIVERED THAT CONVERTED THE VF. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24729606 ↗
• MalfunctionMar 16, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DIFFICULTIES TO BE INTERROGATED. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED WITH THE PROGRAMMER, INCLUDING PROPER POSITIONING AND USE OF THE TELEMETRY WAND; HOWEVER, THIS DEVICE COULD NOT BE READ. THE PROGRAMMER WAS CONFIRMED TO BE COMPATIBLE AND FURTHER EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612468 ↗
• MalfunctionDec 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ALERT. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS, BUT THEY WERE UNSUCCESSFUL. A NEW COMMUNICATOR WAS SHIPPED TO THE PATIENT. LATITUDE RECORD REVIEW DID NOT IDENTIFY A RED CALL ALERT FOR THE REPORTED EVENT; HOWEVER, IT WAS NOTED THAT A PREVIOUS RED ALERT OCCURRED RELATED TO AN OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828596 ↗
• MalfunctionNov 13, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ATRIAL TACHY RESPONSE (ATR) EVENTS DUE TO FARFIELD OVERSENSING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED DETAILED THAT THIS ICD EXHIBITED OVERSENSING OF THE RIGHT ATRIAL (RA) LEAD SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543653 ↗
• InjuryOct 22, 2025Premature Discharge of Battery; Off-Label Use; Premature Discharge of Battery; Off-Label Use

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. IN ADDITION, FC 1003 FOUND FOR OFF LABEL MRI SCAN. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THE LOW VOLTAGE WAS VALID. TS CONFIRMED THAT THE BATTERY VOLTAGE RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION. TECHNICAL SERVICES CONSULTANT RECOMMENDED REPLACEMENT. THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361365 ↗
• MalfunctionOct 21, 2025Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED ATRIAL TACHY RESPONSE (ATR) AND VENTRICULAR EPISODES. THE HCP REPORTED THAT THE PATIENT STATED TO HAVE EXPERIENCED A SHOCK WHILE USING A TENS UNIT MASSAGE DEVICE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). UPON REVIEW, THE STORED ATR SHOWED THERE TO BE OVERSENSING ELECTROMAGNETIC INTERFERENCE (EMI) SIGNALS FROM THE MASSAGE DEVICE WHICH APPEARED TO HAVE CAUSED THE DEVICE TO INAPPROPRIATELY DELIVER A BURST OF ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK. THE SHOCK SUCCESSFULLY CONVERTED THE ARRHYTHMIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23354379 ↗
• InjuryOct 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ATRIAL FIBRILLATION (AF) WITH NORMAL CONDUCTION, BUT THE RATE SPED UP, AND ATP WAS DELIVERED; THE ARRHYTHMIA BROKE SHORTLY AFTER. THEN A SECOND EPISODE OCCURRED, WHERE THE PATIENT AGAIN WENT INTO AF WITH NORMAL CONDUCTION, RATE SPED UP, AND RECEIVED ATP, WHICH DID NOT WORK, AND THEN A SHOCK WAS DELIVERED, WHICH DID NOT BREAK THE RHYTHM, BUT THE ARRHYTHMIA SLOWED OUT OF A TREATMENT ZONE. IT WAS QUESTIONED IF THIS WAS AF WITH RVR OR A DUAL ARRHYTHMIA, POSSIBLE INAPPROPRIATE THERAPY. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS SUSPECTED TO DELIVER 9 BURSTS OF ATP AND ONE ELECTRIC SHOCK FOR WHAT APPEARS TO BE AF WITH RAPID VENTRICULAR RESPONSE (RVR). THE EPISODE SELF-TERMINATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23305990 ↗
• InjuryOct 15, 2025Defibrillation/Stimulation Problem; Inaccurate Synchronization; Defibrillation/Stimulation Problem; Inaccurate Synchronization

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED WITH A RHYTHM THAT THE PHYSICIAN DETERMINED WAS A SLOW VENTRICULAR TACHYCARDIA (VT). A BURST OF COMMANDED ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, FOLLOWED BY BURST OF DEVICE DRIVEN ATP, RESULTING IN THE RHYTHM ACCELERATING INTO VENTRICULAR FIBRILLATION (VF). THEN, THIS DEVICE SUCCESSFULLY DELIVERED A SHOCK AND CONVERTED THE RHYTHM. TECHNICAL SERVICES (TS) WAS CONTACTED AND ANALYZED THE EPISODE DATA AND NOTED THE DEVICE APPEARED TO BE OPERATING AS PROGRAMMED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 23304281 ↗
• InjuryOct 15, 2025Premature Discharge of Battery; Premature 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 OF THIS VOLTAGE CODE MESSAGE WAS VALID WHICH CONFIRMED AS THE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. THIS APPEARED TO BE CONSISTENT WITH CAPACITOR DEGRADATION DUE TO HYDROGEN GAS CONTENT IN THE SEALED DEVICE ATMOSPHERE. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED WITH DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296322 ↗
• MalfunctionSep 12, 2025High impedance; Over-Sensing; Noise, Audible; High impedance; Over-Sensing; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PACING IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE PATIENT HEARD BEEPING TONES AND THERE WAS PRESENCE OF OVERSENSING. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE AND SUSPECTED A SPRING CONTACT BUT HAS NOT BEEN DETERMINED YET. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045515 ↗
• MalfunctionSep 11, 2025Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH A NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD, EXHIBITED A SUDDEN RISE IN PACE IMPEDANCES FROM THE 500-OHMS RANGE TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. SHOCK IMPEDANCE MEASUREMENTS WERE STABLE IN THE 40-50 OHMS RANGE. PRIOR TO AND SINCE THEN, THERE WERE NUMEROUS FALSE EPISODES OF NO THERAPY AND 1 BURST OF ANTI-TACHYCARDIA PACING (ATP) DUE TO OVERSENSED NOISE. THE ATP DID NOT APPEAR TO HAVE CAPTURE. IT WAS NOTED THAT THE PATIENT WAS NOT PACER DEPENDENT AN UNDERLYING RHYTHM WAS OBSERVED. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS INCLUDING POCKET MANIPULATIONS, ISOMETRICS, AND POSSIBLE X-RAYS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. IT WAS NOTED THAT THE ICD WAS EXPLANTED AND UPGRADED TO A DEVICE WITH AN UPDATED HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027833 ↗
• InjuryJul 31, 2025Premature Discharge of Battery; Premature 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 POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683132 ↗
• MalfunctionJun 27, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED OUT OF RANGE RIGHT ATRIAL AND RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS. THE HEALTH CARE PROFESSIONAL REPORTED ISOMETRICS WERE COMPLETED AND NO OVERSENSING WAS OBSERVED. 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 22346858 ↗

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-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