INCEPTA™ ICD E161Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 00802526480768), received between Oct 9, 2017 and Sep 30, 2026 — classified as 180 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (146 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 236 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50955017 ↗
• MalfunctionJul 27, 2026Communication or Transmission Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036230 ↗
• InjuryApr 23, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THE SYSTEM WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD FAILED TO CONVERT ARRHYTHMIA AT INITIAL IMPLANT. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED SHOCK LEAD IMPEDANCE (SLI) HAD BEEN STABLE SINCE 2017. THIS DEVICE WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 24963330 ↗
• InjuryFeb 17, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CALLED TECHNICAL SERVICES (TS) AND REPORTED EXPERIENCING SHOCK EPISODE WHILE RUNNING A CHAINSAW. THE PATIENT ALSO REPORTED EXPERIENCING A SIMILAR EVENT ABOUT FOUR YEARS AGO, HOWEVER, DID NOT GET EVALUATED BY THE CLINICIAN. TS DISCUSSED POSSIBLE CAUSES AND REFERRED PATIENT TO DEVICE TREATING CLINICIAN. SUBSEQUENTLY AT A FOLLOW UP VISIT, THE STORED EPISODES WERE REVIEWED BY THE CLINICIAN. THE CLINICIAN STATED THAT THE MOST RECENT SHOCK EPISODE DELIVERY WAS DEEMED TO BE APPROPRIATE BUT THE SHOCK EPISODE FROM FOUR YEARS AGO WAS DETERMINED TO BE INAPPROPRIATE. THE CLINICIAN DISCUSSED POSSIBLE MEDICATION CHANGES WITH THE PATIENT. AT THIS TIME, THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24370074 ↗
• InjuryJan 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED THREE ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) AND FIVE SHOCKS REACHING THERAPY EXHAUSTION FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF). THE PATIENT WAS HOSPITALIZED. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED FOLLOWING UP WITH THE PHYSICIAN. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Dizziness; Shock from Patient Lead(s)

  MAUDE report 24222343 ↗
• MalfunctionDec 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. IT WAS REPORTED THAT A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE CODE 1003 WAS TRIGGERED INAPPROPRIATELY AND THERE WAS NO INDICATION OF THAT THE BATTERY WAS DEPLETING MORE QUICKLY THAN EXPECTED. HOWEVER THE CODE WOULD REMAIN UNTIL DEVICE CHANGEOUT, WITH A NORMAL 90-DAY CHANGEOUT ONCE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIGGERED. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703840 ↗
• InjuryNov 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525142 ↗
• MalfunctionNov 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) CHANNEL. IT WAS OBSERVED THAT THE RV LEAD WAS NOT A BOSTON SCIENTIFIC PRODUCT. CLINICIAN HAD CONTACTED THE MANUFACTURER FOR THE LEAD WHO RECOMMENDED TO HAVE A COMMANDED SHOCK. TECHNICAL SERVICES (TS) DID NOT DEFER TO THESE RECOMMENDATIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450181 ↗
• InjuryOct 24, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED THREE INAPPROPRIATE SHOCKS. TECHNICAL SERVICES (TS) SUSPECTED THE SHOCKS WERE DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). HOWEVER, THIS WAS UNABLE TO BE CONFIRMED AS THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND BATTERY CAPACITY DEPLETED (BCD). THE DEVICE HAS IMPLANTED FOR 10+ YEARS AND EXPECTATIONS FOR LONGEVITY HAVE BEEN MET. ALSO, THERE WAS A SLIGHT GRADUAL RISE OF SHOCK IMPEDANCE FROM 55 TO 65 OHMS. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380020 ↗
• InjuryOct 15, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DROPPED ITS BATTERY LONGEVITY FROM 2 YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) IN A SPAN OF 14 MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THERE WERE NO FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. HOWEVER, IT WAS NOTED THAT THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY AND WITH THIS THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE. HENCE, THE DEVICE IS MALFUNCTIONING, AND DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287789 ↗
• InjurySep 2, 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 APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932533 ↗
• MalfunctionAug 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) CONFIRMED THIS HAS NOT BEEN A GRADUAL RISE AND THAT THERE IS A HIGH DEGREE OF VARIABILITY UP AND DOWN. REPROGRAMMING WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856375 ↗
• MalfunctionAug 14, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE (SLI) MEASUREMENT OF GREATER THAN 200 OHMS. THE SLI RETURNED TO NORMAL AT THE FOLLOWING DAILY MEASUREMENT. TECHNICAL SERVICES (TS) RECOMMENDED CONTINUOUS MONITORING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WAS SMALL MYOPOTENTIAL NOISE ON THE SHOCK CHANNEL DUE TO AN UNKNOWN SOURCE. TS SUSPECTED IT WAS CAUSED BY ELECTROMAGNETIC INTERFERENCE (EMI) AND RECOMMENDED INVESTIGATING THE SOURCE AS WELL AS LEAD TESTING IN CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806469 ↗
• InjuryMay 27, 2025Premature Discharge of Battery; Defective Device; Premature Discharge of Battery; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. THE PATIENT WAS ALSO REPORTED TO HAVE EXPERIENCED SYMPTOMS OF HEART FAILURE. THE REPLACEMENT PROCEDURE WAS SUCCESSFULLY COMPLETED, AND A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22089095 ↗
• InjuryMay 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible; Incorrect, Inadequate or Imprecise Result or Readings; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED AN ERROR MESSAGE AND WHEN EXAMINED, IT HAD ENTERED SAFETY MODE. ADDITIONALLY, THE DEVICE WAS BEEPING AS A RESULT. 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 21970740 ↗
• InjuryMay 6, 2025Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  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 LOW VOLTAGE FAULT AND THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. ADDITIONALLY, THIS DEVICE EXHIBITED BEEPING TONES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ABOUT BEEPER. TS RECOMMENDED REPLACEMENT. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968287 ↗
• MalfunctionApr 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING SHOCK LEAD IMPEDANCE OUT OF RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935188 ↗
• MalfunctionApr 29, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED AN INAPPROPRIATE SHOCK DUE TO ELECTROCAUTERY BEING USED DURING ANOTHER PROCEDURE. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21927671 ↗
• 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 21855221 ↗
• 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. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854885 ↗
• MalfunctionApr 4, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING INTERVALS DUE TO LARGER PRECEDING SIGNALS. TECHNICAL SERVICES (TS) REVIEWED THE EVENT AND PROVIDED REPROGRAMMING RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774159 ↗
• InjuryMar 14, 2025High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DURING A DEVICE INTERROGATION REVEALED A CODE 1005, INDICATING AN OPEN CIRCUIT CONDITION. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED THE THERAPY EVENT APPEARED TO BE ATRIAL DRIVEN, FOR WHICH THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS AND ONE ANTI-TACHYCARDIA PACING (ATP). TS NOTED THE SECOND SHOCK TRIPPED THE CODE 1005. TS STATED THAT CANNOT GUARANTEE THAT FUTURE SHOCKS WOULD BE ABLE TO CONVERT AND DISCUSSED RV LEAD REPLACEMENT MAY BE NEEDED. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21606587 ↗
• MalfunctionFeb 21, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE OVERSENSING DURING A PROCEDURE WITH ELECTROCAUTERY. ALL OTHER MEASUREMENTS WERE IN RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432922 ↗
• InjuryNov 7, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DROPPED ITS BATTERY LONGEVITY FROM 2 YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) IN A SPAN OF 7 MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED LOW VOLTAGE FAULT WAS TRIGGERED AND THAT THE DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. FURTHERMORE, DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629723 ↗
• InjuryOct 22, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 4 INAPPROPRIATE SHOCK(S) DUE TO AN EPISODE OF ATRIAL ARRHYTHMIA. TROUBLESHOOTING OPTIONS WERE DISCUSSED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20510104 ↗

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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, 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-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-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-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-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