INOGEN™ CRT-D G140Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00802526534539), received between Apr 25, 2016 and Aug 28, 2026 — classified as 2 deaths, 64 injuries, 68 malfunctions.

The most frequently reported specific device problem is “High impedance” (42 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Battery Problem

  Patient problems: Asystole

  MAUDE report 50509690 ↗
• MalfunctionMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1003. AS OF THIS TIME DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725354 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D REMAINS IN SERVICE.ADDITIONAL INFORMATION INDICATES THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 24415308 ↗
• MalfunctionDec 2, 2025Over-Sensing; Use of Device Problem; Over-Sensing; Use of Device Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A SIGNAL ARTIFACT MONITOR (SAM) EVENT, DISABLING THE RESPIRATORY RATE TREND (RRT) FEATURE. THE HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) AND REPORTED THAT THIS OCCURRED DURING A SURGICAL PROCEDURE. TS ADVISED ON TURNING THE RRT FEATURE ON. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701190 ↗
• MalfunctionNov 11, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXHIBITING UNDERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED RA PACING LEAD EVALUATION. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527220 ↗
• InjuryMay 26, 2025Inappropriate/Inadequate Shock/Stimulation; Data Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED MULTIPLE SHOCKS DURING DIFFERENT EPISODES WHILE THE PATIENT WAS ENGAGING IN PHYSICAL ACTIVITY. TECHNICAL SERVICES (TS) WAS CONSULTED, AND IT WAS FOUND THAT THE DEVICE WAS IN END OF LIFE (EOL) STATUS; THEREFORE, NO DATA WAS AVAILABLE FOR REVIEW. TS SUSPECTED THAT THE SHOCKS DELIVERED WERE INAPPROPRIATE. THIS CRT-D WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THIS DEVICE WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS CRT-D HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22084966 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE THAT CORRELATED WITH A VENTRICULAR FIBRILLATION (VF) EPISODE STORED ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ANTI-TACHYCARDIA PACING (ATP) AND ONE 41J SHOCK WERE DELIVERED, BUT THE ARRHYTHMIA APPEARS TO HAVE SPONTANEOUSLY CONVERTED ON ITS OWN AFTERWARDS. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall; Head Injury; Loss of consciousness; Syncope/Fainting

  MAUDE report 22081889 ↗
• 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 21856602 ↗
• InjuryFeb 7, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR AN ATRIAL ARRHYTHMIA. UPON REVIEW, IT WAS NOTED THAT THE DEVICE ALSO RECORDED PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODE. THE DEVICE APPEARED TO BE FUNCTIONING AS PROGRAMMED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21333592 ↗
• MalfunctionDec 4, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED, AND IT WAS FOUND THAT THIS CRT-D HAD PRESENTED THIS BEHAVIOR IN THE PREVIOUS SIX MONTHS. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI), AND ALL OTHER MEASUREMENTS WERE IN RANGE POST MRI. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849310 ↗
• MalfunctionNov 29, 2024Signal Artifact/Noise; Under-Sensing; Signal Artifact/Noise; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SOME UNDERSENSING OF THE ATRIAL FIBRILLATION (AF) OF THIS PATIENT. NOISE WAS ALSO NOTED BUT EFFECTIVELY WAS NOT SENSED. THE PLAN IS CONTINUING TO BE MONITORED. CURRENTLY, THIS CRT-D REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20812316 ↗
• InjuryOct 21, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PACING INHIBITION AND OVERSENSING RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). UPON REVIEW, IT WAS DETERMINED THAT THE PATIENT HAD CHRONIC ATRIAL FIBRILLATION (AF) THAT WAS OVERSENSING. TROUBLESHOOTING OPTIONS WERE DISCUSSED AND NO PROGRAMMING OPTIONS WERE AVAILABLE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT NOISE WAS NOISE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 20500907 ↗
• MalfunctionJul 19, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) SYSTEM OVERSENSED NOISE ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD LEADING TO INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. TECHNICAL SERVICES (TS) REVIEWED THE DATA, AND THE MEASUREMENTS WERE IN RANGE. THERE WERE NO PROGRAMMING CHANGES DUE TO HISTORY OF ATRIAL FIBRILLATION (AF). FURTHER MONITORING WITH THE CARDIOLOGIST WAS RECOMMENDED. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784508 ↗
• InjuryJun 18, 2024High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED CODE 1005 INDICATING THAT AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY. THE PHYSICIAN PERFORMED A DEFIBRILLATION THRESHOLD (DFT) TEST. THE BOSTON SCIENTIFIC REPRESENTATIVE ASKED WHY A DFT TEST WAS PERFORMED. THE PHYSICIAN STATED THAT THE IMPEDANCE HAS BEEN A LITTLE HIGH. TECHNICAL SERVICES (TS) REVIEWED THE CODE AND RESOLUTION RECOMMENDATIONS. THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559019 ↗
• MalfunctionMay 16, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED NOISE AND OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL. THE PATIENT HAD CALLED IN AND STATED THAT THEY HAD UNCOMFORTABLE STIMULATION THE PREVIOUS NIGHT. THE HEALTH CARE PROFESSIONAL (HCP) REVIEWED DEVICE SETTINGS AND WERE NOT ABLE TO SEE ANY AUTO TESTS THAT COULD HAVE CAUSED THIS. TECHNICAL SERVICES (TS) STATED THAT THERE WERE NO AUTO THRESHOLD TESTS AVAILABLE FOR THIS DEVICE. TS STATED THAT IT COULD BE RIGHT ATRIAL (RA) INSULATION ISSUE. THERE WAS ASYSTOLE FOR MORE THAN 2 SECONDS, HOWEVER THE PATIENT HAD ITS OWN INTRINSIC RA MARCHING THROUGH NOISE. TS RECOMMENDED TO HAVE FURTHER TESTING DONE IN THE CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Device Overstimulation of Tissue

  MAUDE report 19332409 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19113094 ↗
• MalfunctionFeb 3, 2024Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED INTERROGATION DIFFICULTIES. THE PHYSICIAN WAS USING THE CORRECT WAND. THE PATIENT HAD A VENTRICULAR TACHYCARDIA STORM WITH MULTIPLE THERAPIES. FURTHERMORE, THE PATIENT WAS INTUBATED AND NOT CONSCIOUS. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636995 ↗
• MalfunctionJan 10, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REQUESTED DUE TO THE PATIENT EXPERIENCING PALPITATIONS. UPON REVIEW, TECHNICAL SERVICES (TS) NOTED POSSIBLE RIGHT ATRIAL (RA) LEAD LOSS OF CAPTURE (LOC). TS REVIEWED TROUBLESHOOTING OPTIONS, AND RA LEAD EVALUATION WAS RECOMMENDED. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Heart Problem

  MAUDE report 18490398 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF SYSTEM REVISION DUE TO POCKET INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18388549 ↗
• MalfunctionOct 24, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING, LEADING TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY. REPROGRAMMING EFFORTS WERE PERFORMED AND RECOMMENDED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997309 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17638013 ↗
• MalfunctionJul 18, 2023High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS AN ALERT ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL PACING IMPEDANCE MEASUREMENTS BEING OUT-OF-RANGE. TECHNICAL SERVICES (TS) ANALYZED THE PRESENTING ELECTROGRAM (EGM) AND FOUND THAT THERE WERE MEASUREMENTS THAT WERE HIGH OUT-OF-RANGE. TS ADVISED FURTHER MONITORING OF THIS SITUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RIGHT ATRIAL (RA) LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC. CURRENTLY, THIS CRT-D REMAINS IN SERVICE. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342902 ↗
• InjuryMar 17, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS ON THE LEFT VENTRICULAR (LV) LEAD. REPROGRAMMING EFFORTS WERE PERFORMED AND THE PLAN IS CONTINUING TO BE MONITORED. AT THIS TIME, THE PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565654 ↗
• InjuryFeb 24, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO DAMAGE NOTED DURING A LEAD REVISION PROCEDURE. WHILE IMPLANTING A RIGHT VENTRICULAR (RV) LEAD AND CONNECTING THE LEAD TO THE CRT-D, DAMAGE TO THE INSULATION ON THE SCREW OF THE HEADER WAS DETECTED. IT WAS NOT KNOWN IF THE DAMAGE WAS CAUSED BY THE USER OR IF IT WAS DAMAGED PRIOR. THE CRT-D WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435873 ↗
• InjuryJan 9, 2023Failure to Convert Rhythm; Inaccurate Synchronization; Failure to Convert Rhythm; Inaccurate Synchronization

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), PRESENTED FOR A ROUTINE FOLLOW-UP AND HAD MENTIONED THAT THE PATIENT WAS HOSPITALIZED IN MAY WITH VENTRICULAR FIBRILLATION (VF). THE EPISODE SHOWED ANTI-TACHYCARDIA PACING (ATP) WITH FIVE 41 JOULE SHOCKS. THE ATP ACCELERATED THE VF AND THE DEVICE DELIVERED FOUR SHOCKS WITHOUT SUCCESS, THE FIFTH SHOCK CONVERTED THE VF RHYTHM, AND THE SHOCK IMPEDANCE WAS IN RANGE. THE PHYSICIAN SUSPECTS THAT THE INEFFECTIVE SHOCKS WERE NOT DUE TO THE DEVICE BUT POSSIBLY DUE TO PATIENT CONDITION LAMINA. THE ATP PRE-SHOCK WAS DISABLED, AND THE PLAN IS TO PERFORM AN X-RAY TO EVALUATE THE POSITION OF THE LEAD COIL AT THE NEXT FOLLOW-UP IN THE NEXT SIX TO EIGHT MONTHS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IN-SERVICE.

  Patient problems: Electric Shock; Ventricular Fibrillation

  MAUDE report 16127419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, 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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.