ENERGEN™ ICD E143Recalls & reported problems

Summary

The FDA's MAUDE database contains 430 adverse event reports that list this exact device (DI 00802526480744), received between Jul 12, 2017 and Sep 18, 2026 — classified as 1 death, 310 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (198 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 430 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50823282 ↗
• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600560 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354661 ↗
• InjuryAug 18, 2026Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to an product performance issue. This ICD was successfully explanted and replaced with another lead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311725 ↗
• InjuryApr 1, 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 SEPTICEMIA. THE PHYSICIAN REQUESTED A REVIEW OF THE REPORT. TECHNICAL SERVICES (TS) PROVIDED A REVIEW OF THE REPORT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24756320 ↗
• InjuryMar 9, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PRESENTED TO THE EMERGENCY ROOM (ER) WITH CHEST PAIN. THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION (AF), HOWEVER, WAS CARDIOVERTED. IN ADDITION, THERE WAS A PACEMAKER MEDIATED TACHYCARDIA (PMT) RECORDED, AND THE PATIENT WILL BE ADMITTED. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 24547093 ↗
• InjuryMar 3, 2026Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A CHARGED TIME OF 15.3 SECONDS AND BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT THIS WAS SECONDARY EXPLANT MECHANISM FOR PATIENT'S SAFETY. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT THIS ICD WAS EXPLANTED WITH NO REPLACEMENT AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500612 ↗
• InjuryFeb 20, 2026Battery Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DIFFICULTY BEING INTERROGATED. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED DEVICE REPLACEMENT. ADDITIONALLY, IT WAS NOTED THAT THE ICD APPEARED TO HAVE DEPLETED PREMATURELY. THIS ICD WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404975 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PAIN AT THE IMPLANT SITE AND FELT LIKE THE LEADS CAME LOOSE. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE TRANSMISSION REPORT, NOTED ATRIAL ARRHYTHMIA AND NON-SUSTAINED EPISODES PRESENT IN CONFIGURED COLLECTION PERIOD AND PRESENTING ELECTROGRAM SHOWED DEVICE OPERATING AS PROGRAMMED. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 23804534 ↗
• InjuryOct 8, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECREASED FROM 10 MONTHS TO 3 MONTHS IN A SPAN OF 2 MONTHS. TECHNICAL SERVICES (TS) ASSESSED AND INDICATED THAT THE POWER CONSUMPTION MEASURED AT 34 MICROWATTS, WITH NO RECENT ATRIAL FIBRILLATION (AF) EPISODES, CAPACITOR REFORMS, EXCESSIVE INTERROGATIONS, OR ACTIVE ADVISORIES. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THE DEVICE SHOWED NO LOW VOLTAGE FAULT, BUT DEPLETION PATTERN MATCHED THE 2013 LV CAPACITORS ADVISORY. THE BATTERY VOLTAGE WAS 2.910 VOLTS WITH THERAPY UNAFFECTED. THE BATTERY STATUS INDICATORS WERE INACCURATE DUE TO UNDETECTED ENERGY LOSS. THE DEVICE MALFUNCTION CONFIRMED; REPLACEMENT AND RETURN FOR ANALYSIS WAS RECOMMENDED. THE DAILY POWER FLUCTUATIONS WERE STEADY, WITH SUFFICIENT RESERVE FOR 90 DAYS BEFORE REASSESSMENT OR REPLACEMENT. THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23245419 ↗
• MalfunctionSep 17, 2025Signal Artifact/Noise; Over-Sensing; Under-Sensing; Low impedance; Noise, Audible; Signal Artifact/Noise; Over-Sensing; Under-Sensing; Low impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISY SIGNALS AND PACING IMPEDANCE MEASUREMENTS LOW OUT OF RANGE ON THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING EFFORTS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD STATING BEEPING TONES WERE HEARD DUE TO THE OUT OF RANGE ALERT FOR PACING IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT THERE WAS NOISE OVERSENSING FOLLOWED BY UNDERSENSING OF A P WAVE SIGNAL. TS PROVIDED NEW TROUBLESHOOTING OPTIONS FOR THESE ISSUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073228 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO POCKET INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22236069 ↗
• MalfunctionMay 22, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Low impedance; Signal Artifact/Noise; Failure to Capture; High impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD CHANNEL OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS SHOWN NOTABLE CHANGES. RA NOISE AND LOW IMPEDANCES WERE NOTED ON THE RA CHANNEL DATING BACK TO 2022. IN EARLY APRIL, THIS PATIENT EXPERIENCED A CAR ACCIDENT. SINCE THE ACCIDENT, THE IMPEDANCES HAVE NOW BEEN INCREASING, AND NO CAPTURE HAS BEEN NOTED ON THE ATRIAL CHANNEL. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND SUSPECTS LEAD INSULATION DAMAGE AND FRACTURE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD VIA GFE THAT THE ATRIAL CHANNEL WAS PROGRAMMED OFF, AND THERE WAS NO LOSS OF CAPTURE. THE OBSERVED LOW IMPEDANCES ARE A LEAD SPECIFIC ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075100 ↗
• MalfunctionMay 22, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM RECORDED A CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED DURING SHOCK DELIVERY DUE TO A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. FURTHER TESTING AND REPROGRAMMING OPTIONS WERE RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070662 ↗
• MalfunctionMay 13, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK. TECHNICAL SERVICES RECOMMENDED PROGRAMMING CHANGES. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22012079 ↗
• InjuryApr 24, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING AND DELIVERED TWO INAPPROPRIATE SHOCKS DUE TO SUPRAVENTRICULAR TACHYCARDIA. TECHNICAL SERVICES (TS) ADVISED AFTER THE SECOND INAPPROPRIATE SHOCK THE RHYTHM SLOWED AND FELL BELOW THE RATE CUTOFF. IN ADDITION, TS PROVIDED REPROGRAMMING RECOMMENDATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21900737 ↗
• InjuryApr 23, 2025Pacing Problem; Inaccurate Synchronization; Under-Sensing; Pacing Problem; Inaccurate Synchronization; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED A THERAPY EVENT WHICH BEGAN WITH INHIBITING THERAPY APPROPRIATELY FOR ATRIAL TACHYCARDIA (AT). HOWEVER THE AT HAD A LONG A-V, AND ONE ATRIAL BEAT WAS UNDERSENSED, GIVING THE APPEARANCE OF V>A. AS A RESULT, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, WHICH ACCELERATED THE PATIENT'S RHYTHM TO THE VENTRICULAR FIBRILLATION (VF) ZONE. THEN, A SHOCK IS DELIVERED AND BREAKS THE ARRHYTHMIA. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 21896314 ↗
• MalfunctionApr 18, 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 21864604 ↗
• 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 21854450 ↗
• 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. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853450 ↗
• 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 21853449 ↗
• InjuryApr 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED CHRONIC HIGH OUT OF RANGE SHOCK LEAD IMPEDANCES MEASURING 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21843906 ↗
• InjuryApr 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21781768 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DEVELOPED A LARGE HEMATOMA AFTER FALLING AND SUSTAINING AN IMPACT TO THE DEVICE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO ADDRESS THE HEMATOMA AT THE ICD IMPLANTATION SITE. DURING THIS PROCEDURE, THE ICD, ALONG WITH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, WERE SURGICALLY ABANDONED, AND THE SYSTEM WAS NOT REPLACED. THE RA LEAD IS A NON-BOSTON SCIENTIFIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 21749132 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO UNKNOWN REASON. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715570 ↗

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-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-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