ENERGEN™ CRT-D N141Recalls & reported problems

Summary

The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 00802526480966), received between Oct 12, 2016 and Jan 26, 2026 — classified as 2 deaths, 139 injuries, 88 malfunctions.

The most frequently reported specific device problem is “High impedance” (59 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 229 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Premature Discharge of Battery; Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO BE DEPLETING PREMATURELY. TONES WAS EMITTED. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177942 ↗
• InjuryJul 8, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS SUSPECTED TO BE DEPLETING PREMATURELY AND REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER INDICATING MONTHS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED LIKELY DUE TO CHARGE TIME (CT). THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22432820 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EXHIBITED POSSIBLE INFECTION. REPORTEDLY, THE WAS PATIENT COMPLAINED OF A LARGE LUMP AT THE IMPLANT SITE AND STATED THAT THE DEVICE WAS SOMEWHAT STICKING UP. AS OF THIS TIME, THE CRT-D WITH THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 22116742 ↗
• 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 ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861055 ↗
• 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 21854415 ↗
• 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 21854094 ↗
• 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 21853615 ↗
• 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 21853589 ↗
• InjuryMar 7, 2025Battery Problem; Noise, Audible; Battery Problem; Noise, Audible

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EMITTED BEEPING TONES AND HAD YEAR BATTERY REMAINING LEFT MONTHS AGO. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS ABLE TO DISCUSS THE BEEPING PATTERN OF THE DEVICE AND THE POSSIBLE CAUSES. TS THEN REFERRED THE PATIENT TO THE CLINIC TO CONFIRM CAUSE OF THE BEEPING. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549860 ↗
• InjuryNov 29, 2024Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO CONCERNS OF PREMATURE BATTERY DEPLETION (PBD) AS IT DECREASED FROM 1 YEAR REMAINING TO END OF LIFE (EOL) IN A 7 MONTHS TIME PERIOD. THE PATIENT EXPERIENCED TWO SYNCOPAL EPISODES DURING THIS TIME. A DEVICE CHANGEOUT PROCEDURE WAS PERFORMED AND IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Loss of consciousness; Syncope/Fainting

  MAUDE report 20810855 ↗
• MalfunctionNov 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED FELL AND HAD TO GO TO THE HOSPITAL TO HAVE THE SETTINGS RE-ADJUSTED. AS THE REASON WAS DUE TO THE SETTINGS WERE NOT SET CORRECTLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THE PHYSICIAN. AS OF THIS TIME, THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall

  MAUDE report 20586967 ↗
• MalfunctionOct 31, 2024Off-Label Use; Device Sensing Problem; Off-Label Use; Device Sensing Problem

  IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE WHEN THEY TOOK THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) OUT OF THE POCKET THEY LOST PACING ON BOTH THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS. TECHNICAL SERVICES DISCUSSED THAT RV OVERSENSING WILL INHIBIT BOTH CHANNELS. BOTH LEADS WERE TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) AND EVERYTHING WAS FINE. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. LEAD TESTING WAS PERFORMED AND THERE WERE NO ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580742 ↗
• InjuryOct 18, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; 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 NOISE AND OVERSENSING. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WAS EXPLANTED EIGHT YEARS AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20487887 ↗
• MalfunctionOct 14, 2024Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A FALL AND A LARGE HEMATOMA APPEARED ON TOP OF THE CRT-D. THE FIELD REPRESENTATIVE WAS UNABLE TO INTERROGATE THE CRT-D. RECOMMENDATIONS WERE GIVEN TO DETERMINE IF THERE WAS A DEVICE DAMAGE. THE CRT-D REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443877 ↗
• InjurySep 27, 2024Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED A DECREASE IN THE ESTIMATED BATTERY LONGEVITY AND DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI), DESPITE PREVIOUSLY INDICATING 8 MONTHS OF REMAINING LIFE. TECHNICAL SERVICES (TS) WERE CONSULTED AND CONFIRMED THAT ERI WAS TRIGGERED BY A CHARGE TIME OF 16 SECONDS. ADDITIONALLY, A GRADUAL INCREASE IN POWER CONSUMPTION OVER THE PAST FEW YEARS WAS ALSO CONFIRMED. TS RECOMMENDED REPLACING THE DEVICE WITHIN 90 DAYS OR SOONER DUE TO CONCERNS ABOUT THE LONG CHARGE TIME. THE DEVICE REMAINS IMPLANTED AND IN SERVICE, WITH NO REPORTED ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20325619 ↗
• InjurySep 2, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED VARIOUS EPISODES OF INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR CHANNEL. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE WENT OUT OF SERVICE APPROXIMATELY EIGHT YEARS AFTER IMPLANTING DUE TO THE PATIENT PASSING AWAY DUE TO UNRELATED REASONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20122463 ↗
• MalfunctionAug 5, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT RANGE SHOCK IMPEDANCE MEASUREMENTS WHEN IT WAS EXAMINED DURING A CHANGEOUT DUE TO NORMAL BATTERY DEPLETION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE DEVICE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913303 ↗
• InjuryJul 16, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748378 ↗
• InjuryMay 14, 2024Signal Artifact/Noise; Over-Sensing; Low impedance; Delayed Charge Time; Battery Problem; Signal Artifact/Noise; Over-Sensing; Low impedance; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THERE WERE CONCERNS ABOUT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)'S BATTERY LONGEVITY. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THERE WAS A DELAY IN CHARGE TIMES THAT RESULTED IN THE DEVICE REACHING EXPLANT. ADDITIONALLY, THE DEVICE EXHIBITED JUMPY LOW OUT OF RANGE PACING IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD CHANNEL AND HAD ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO OVERSENSING OF NOISY SIGNALS. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314217 ↗
• InjuryMay 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO UNKNOWN ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256694 ↗
• InjuryApr 4, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LONGEVITY CALCULATIONS FROM 10 MONTHS TO 3 MONTHS REMAINING IN A SPAN OF 1 MONTH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE IS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUGGESTED TO SEND FILE FOR ANALYSIS TO CONFIRM BUT HEALTH CARE PROFESSIONAL (HCP) DECLINED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040510 ↗
• InjuryMar 26, 2024Over-Sensing; Battery Problem; Over-Sensing; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXHIBITING RIGHT VENTRICULAR (RV) INTERMITTENT OVERSENSING OF ATRIAL ACTIVITY. BATTERY CAPACITY HAD DECREASED DUE TO EXTENDED CHARGE TIMES. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPROGRAMMING AND SYSTEM EVALUATION OPTIONS. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979844 ↗
• MalfunctionMar 12, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS FOR THE LAST 6 MONTHS. THERE WAS NO EVIDENCE OF LV NOISE. A RECENT THRESHOLD MEASUREMENT WAS 2.2V @ 1MS AND SENSING WAS 14.2 MV. THE PATIENT WAS REFERRED TO CARDIOLOGY. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887453 ↗
• InjuryMar 6, 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. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD LONG STANDING INFECTION WITH POSITIVE BLOOD CULTURES. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-D WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18844421 ↗
• MalfunctionFeb 21, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REVEALED NOISE ON ALL CHANNELS, RESULTING IN OVERSENSED NOISE WITH PACING INHIBITION ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE PATIENT APPEARED TO HAVE AN ESCAPE RHYTHM AND THERE WAS NO INDICATION OF PAUSES GREATER THAN TWO SECONDS. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS, PROGRAMMING CONSIDERATIONS, AND POSSIBLE CAUSES. IT WAS NOTED THAT THE PACEMAKER WAS NEARING REPLACEMENT AND THEY MAY CONSIDER REVISING THE LEADS AT THAT TIME. THIS PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754742 ↗

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-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-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-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-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-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.