INCEPTA™ CRT-D N160Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00802526480997), received between Jan 24, 2018 and Apr 15, 2026 — classified as 1 death, 67 injuries, 40 malfunctions.

The most frequently reported specific device problem is “High impedance” (37 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 108 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885083 ↗
• MalfunctionJun 2, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A NORMAL BATTERY DEPLETION DEVICE REPLACEMENT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS HAVING INTERROGATION ISSUES. IT WAS NOTED THAT THE CONNECTION WAS SLUGGISH AND COULD NOT BE MAINTAINED WITHOUT PHYSICAL PROXIMITY TO THE DEVICE. MULTIPLE PROGRAMMERS AND TELEMETRY WANDS WERE ATTEMPTED BUT DID NOT RESOLVE THIS. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THIS DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124501 ↗
• 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. THE ASSOCIATED RV LEAD WAS TAKEN OUT OF SERVICE; HOWEVER, THIS DEVICE REMAINED IN SERVICE AT THE TIME OF PROCEDURE AND WAS SUBSEQUENTLY REMOVED FROM SERVICE AT A LATER DATE TO AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856449 ↗
• InjuryFeb 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO A NON-SPECIFIC PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465324 ↗
• MalfunctionFeb 11, 2025Failure to Capture; High impedance; Battery Problem; Device Sensing Problem; Failure to Capture; High impedance; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THIS PATIENT'S PACEMAKER WAS BEEPING. UPON INTERROGATION IN CLINIC, IT WAS FOUND THAT THE PACEMAKER WAS AT ITS ELECTIVE REPLACEMENT INDICATOR (ERI). AT LAST CHECK APPROXIMATELY THREE MONTHS PRIOR, THE BATTERY LIFE ESTIMATE WAS ONE YEAR LEFT. AN ANALYSIS OF DEVICE DATA TO DETERMINE BATTERY STATUS WAS DECLINED. IT WAS ALSO FOUND THAT THE INTRINSIC AMPLITUDE OF THE LEFT VENTRICULAR (LV) LEAD WAS HIGH AT GREATER THAN 25 MV ALONG WITH INTERMITTENT LOSS OF CAPTURE (LOC) AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355891 ↗
• InjuryOct 17, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EPISODES OF INAPPROPRIATE SHOCKS DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20477910 ↗
• InjuryOct 6, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND ELECTRIC SHOCK FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMMING OPTIONS. PHYSICIAN WAS DISCUSSING AF ABLATION. DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20380055 ↗
• InjuryAug 22, 2024High impedance; Delayed Charge Time; Battery Problem; High impedance; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DEVICE INFORMATION AS WELL AS THERAPY DELIVERY. THE CRT-D EXHIBITED THE ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS DUE TO A CHARGE TIME OF OVER 15 SECONDS DURING CAPACITOR REFORM. PREVIOUS DATA UPLOAD INDICATED TWO YEARS OF BATTERY LONGEVITY REMAINING. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031129 ↗
• InjuryJul 11, 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 A SYSTEM REVISION DUE TO INFECTION AND ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 19726978 ↗
• InjuryJul 9, 2024Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WENT FROM 1 YEAR OF LONGEVITY REMAINING TO ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS IN A SPAN OF FOUR MONTHS. ADDITIONALLY, CHARGE TIMES WERE NOTED TO HAVE INCREASED. FURTHER INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705556 ↗
• InjuryMay 21, 2024Extracardiac stimulation; Adverse Event Without Identified Device or Use Problem; Extracardiac stimulation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED HICCUPS AND WAS FEELING ABDOMINAL PAIN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADJUSTMENTS WERE DONE TO THE DEVICE FOR PHRENIC NERVE STIMULATION. SUBSEQUENTLY, THIS CRT-D WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Abdominal Pain; Device Overstimulation of Tissue; Hiccups

  MAUDE report 19367885 ↗
• InjuryApr 30, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A LEFT VENTRICULAR (LV) LEAD WAS BEING REPLACED. THE PATIENT IS LV AND RIGHT VENTRICULAR LEAD PACING DEPENDENT. THE LV LEAD HAD BEEN SHOWING HIGH PACING THRESHOLDS. WHEN THE CRT-D WAS TAKEN OUT OF THE POCKET AND THE RV LEAD WAS DISCONNECTED, THE LV LEAD SHOWED LOSS OF CAPTURE (LOC). THE CRT-D WAS REPLACED FOR A NEW ONE AND THE LV LEAD REMAINS IN SERVICE. AT THIS TIME THE CRT-D HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19218356 ↗
• MalfunctionMar 28, 2024Over-Sensing; Pacing Problem; Under-Sensing; Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FARFIELD SIGNAL OVERSENSING AND ATRIAL UNDERSENSING WITH COMPETITIVE PACING WHILE IN A MODE SWITCH. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE MODEL/SERIAL NUMBER AND PATIENT INFORMATION WITHOUT SUCCESS. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WOULD BE UPDATED AT THAT TIME. EVIDENCE SUGGESTS THIS CRT-D REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994203 ↗
• InjuryDec 29, 2023No Audible Alarm; Noise, Audible; No Audible Alarm; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED BEEPING TONES AND THE THERAPY HAS BEEN PROGRAMMED OFF FOR SOME TIME. FIELD REPRESENTATIVE DID NOT HAVE ANY INFORMATION WHEN THE THERAPY WAS PROGRAMMED OFF. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418452 ↗
• MalfunctionNov 30, 2023Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT, DURING THE EXPLANT PROCEDURE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT EXHIBITED OVERSENSING FROM ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE ELECTROCAUTERY, LEADING INTO PACING INHIBITION, UNDERSENSING AND LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) EXPLAINED TO THE FIELD REPRESENTATIVE THAT THIS IS INDICATIVE OF DEFIBRILLATOR DETECT CIRCUIT BEHAVIOR. NO ASYSTOLE WAS EXHIBITED. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238732 ↗
• MalfunctionOct 17, 2023Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED AN ALERT FOR LOW OUT OF RANGE SHOCK AND PACE IMPEDANCE MEASUREMENTS. SHOCK IMPEDANCE MEASUREMENTS WERE SET TO 0 OHMS. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE CONFIRMED THAT THE PATIENT WAS EVALUATED IN THE CLINIC AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN RANGE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE DAY THE ALERTS WERE DISPLAYED. IT IS PLANNED TO CONTINUE TO MONITOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951419 ↗
• MalfunctionOct 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS FOR THE LAST YEAR AND A HALF. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES, INCLUDING POSSIBLE LEAD CALCIFICATION. THIS CRT-D SYSTEM REMAINS IN SERVICE, AND WILL CONTINUE TO BE MONITORED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890246 ↗
• InjurySep 26, 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 A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17815877 ↗
• InjurySep 15, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE AND HAD A LEAD FAILURE. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756906 ↗
• InjurySep 11, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED HIGH OUT IN RANGE SHOCK IMPEDANCE VALUES. IT WAS NOTED THAT THE PATIENT HAD BEEN EVALUATED, AND DEFIBRILLATION THRESHOLD (DFT) TESTING HAD BEEN UNSUCCESSFUL IN VARIOUS SHOCKING CONFIGURATIONS. THIS CRT-D WAS SUBSEQUENTLY EXPLANTED. DUE TO PATIENT ANATOMY, A REPLACEMENT SYSTEM WAS PLANNED TO BE IMPLANTED AT A FUTURE DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17725946 ↗
• MalfunctionAug 17, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED PACING INHIBITION IN THE LEFT VENTRICULAR (LV) LEAD CHANNEL. IT WAS DISCUSSED THAT ATRIAL OVER SENSING WAS LIKELY THE CAUSE. PROGRAMMING OPTIONS WERE DISCUSSED FOR THIS CRT-D AS A RESOLUTION. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17562791 ↗
• MalfunctionAug 2, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD TRIGGERED A RED ALERT DUE TO A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES. THIS CRT-D SYSTEM REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17447524 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17367953 ↗
• InjuryJul 19, 2023High impedance; Pacing Problem; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IT WAS DECIDED TO ADDRESS THE ISSUE AT THE NEXT DEVICE REPLACEMENT. ADDITIONALLY, THIS PATIENT EXPERIENCED EPISODES OF PACEMAKER MEDIATED TACHYCARDIA (PMT). THE DEVICE'S ALGORITHM SUCCESSFULLY TERMINATED THE EPISODE OF PMT. DURING THE REPLACEMENT PROCEDURE A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED IN ORDER TO EVALUATE THE MEASUREMENTS, ALTHOUGH THEY WERE TRENDING DOWN, THEY WERE STILL OUT OF RANGE. THIS DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Electric Shock

  MAUDE report 17356576 ↗
• MalfunctionJun 7, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONTACTED REGARDING CROSSTALK OVERSENSING BEING FLAGGED BY A THIRD PARTY REVIEWER, DESPITE IT FALLING WITHIN THE DEVICE'S BLANKING PERIOD. TS DISCUSSED THE PHENOMENON WITH THE PHYSICIAN, AND THEY BOTH AGREED THE CROSSTALK WAS BEING APPROPRIATELY BLANKED BY THE DEVICE. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081573 ↗

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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, 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-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-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-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-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-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-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-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.