INOGEN™ MINI ICD DR D012Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00802526533822), received between Apr 22, 2016 and Dec 5, 2023 — classified as 76 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (28 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO POSSIBLE RESPIRATORY RATE TREND (RRT) OVERSENSING. TECHNICAL SERVICES REVIEWED THE CASE AND STATED THAT THE RRT FEATURE WAS ON, BUT THIS ICD DID NOT HAVE THE NEWEST FIRMWARE THAT ADDS THE SIGNAL ARTIFACT MONITORING (SAM) FEATURE AND RECOMMENDED TO BRING THE PATIENT FOR IN-CLINIC INTERROGATION. SAM SHOULD BE DOWNLOADED TO THIS DEVICE. NO ERRATIC OR HIGH IMPEDANCE WAS NOTICED. FURTHER INFORMATION WAS RECEIVED INDICATING THAT THE FIRMWARE WAS UPDATED, AND THE ATRS WERE CONFIRMED TO BE CAUSED DUE TO RRT OVERSENSING. THIS ICD REMAINED IN SERVICE AND WAS EVENTUALLY EXPLANTED AND REPLACED DUE TO A NORMAL BATTERY DEPLETION. THE PRODUCT WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE EVER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268478 ↗
• InjurySep 28, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THERE IS A CONCERN FOR A SUSPECTED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PERFORMED AN ANALYSIS IN WHICH IT WAS DETERMINED THAT THERE MAY BE INAPPROPRIATE THERAPY FOR A SUPRAVENTRICULAR TACHYCARDIA. IT WAS ALSO NOTED THAT THERAPY EXHAUSTION OCCURRED; TS RECOMMENDED PROGRAMMING ENHANCEMENTS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17840388 ↗
• InjuryJul 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A YELLOW ALERT 1007 RELATED TO CAPACITOR CHARGE TIME EXCEEDING THE LIMIT. THE DEVICE WAS RECOMMENDED TO BE EXPLANTED AND HAS BEEN EXPLANTED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245120 ↗
• MalfunctionJun 26, 2023Signal Artifact/Noise; High impedance; Noise, Audible; Signal Artifact/Noise; High impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL. ADDITIONALLY, THE DEVICE STARTED EMITTING AUDIBLE TONES DUE TO HAVING REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). TROUBLESHOOTING, MONITORING AND A POTENTIAL DEVICE REPLACEMENT WERE DISCUSSED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203860 ↗
• InjuryMar 31, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD CHANGEOUT AS THE DEVICE WAS DEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) HAS NO FURTHER INFORMATION. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656696 ↗
• InjuryFeb 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED TO THE ATTENDING PHYSICIAN TO CLARIFY THE MEANING OF DEVICE BEING DEAD. THIS DEVICE WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386626 ↗
• InjuryJan 2, 2023Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME OF OVER FIFTEEN SECONDS. DUE TO THIS, THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THIS DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082672 ↗
• InjuryNov 3, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE IS EXHIBITING POTENTIAL PREMATURE BATTERY DEPLETION BEHAVIOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT THE DEVICE RECENTLY REACHED EXPLANT INDICATOR STATUS DUE TO A CAPACITOR CHARGE TIME OF 16.2 SECONDS. TS NOTED THAT THE DEVICE WILL STILL HAVE A 90 DAY REPLACEMENT WINDOW BUT THEY COULD CONSIDER REPLACING THE DEVICE SOONER DUE TO THE EXTENDED CHARGE TIME. TS OFFERED TO PERFORM AN ANALYSIS OF DEVICE DATA, BUT THE HEALTHCARE PROVIDER STATED THEY WILL INFORM THE PHYSICIAN AND GO FROM THERE. THE DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722228 ↗
• InjuryOct 12, 2022Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED CHARGE TIME CRITERIA TO DECLARE ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONAL INFORMATION WAS OBTAINED, AND THE REPRESENTATIVE STATED THAT A LONGEVITY ISSUE WAS NOTED ALONG WITH LONG CHARGE TIMES. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587282 ↗
• InjurySep 6, 2022Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED A BATTERY CAPACITY DEPLETED STATUS FOR APPROXIMATELY ONE YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THIS WAS FOUND TO BE DUE TO EXTENDED CHARGE TIMES AND RECOMMENDED DEVICE REPLACEMENT. CURRENTLY, EVIDENCE SUGGESTS THAT THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366162 ↗
• InjuryJun 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY LONGEVITY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT FROM NINE MONTHS REMAINING TO ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS IN A SPAN OF ONE MONTH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OPTION DOING SAVE TO DISK AND SENDING FILE. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690533 ↗
• InjuryApr 26, 2022Adverse 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 14214627 ↗
• InjuryApr 22, 2022Adverse 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: Sepsis; Unspecified Infection

  MAUDE report 14182337 ↗
• MalfunctionApr 18, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND CURRENTLY IN END OF LIFE (EOL) STATUS. ADDITIONALLY, HEALTH CARE PROFESSIONAL (HCP) CONFIRMED PATIENT SEEMS EXHAUSTED AND LESS PEPPY THAN USUAL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED PLAINLY THAT THE PATIENT'S IMPLANTED DEVICE NEEDS TO BE REPLACED AS SOON AS POSSIBLE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138673 ↗
• InjuryMar 25, 2022Adverse 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 WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 13912337 ↗
• MalfunctionFeb 3, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THERE IS NO INTERVENTION INFORMATION AVAILABLE TO DATE AND THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444893 ↗
• InjuryJan 17, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS SUSPECTED TO BE DEPLETING PREMATURELY. THIS DEVICE WAS REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13270247 ↗
• MalfunctionJan 1, 2022High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES MEASURING GREATER THAN 3000 OHMS ON THE RIGHT ATRIAL (RA) LEAD THAT WERE BEING OVERSENSED BY THE RESPIRATORY RATE TREND (RRT) SENSOR. TECHNICAL SERVICES RECOMMENDED TO TURN OFF THE RRT SENSOR. AT THIS TIME, THE ICD AND RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137555 ↗
• MalfunctionDec 20, 2021Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DELIVERED INAPPROPRIATELY ANTI TACHYCARDIA PACING AND 8 SHOCKS DUE TO SUPRAVENTRICULAR TACHYCARDIA. DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 13048419 ↗
• MalfunctionNov 3, 2021Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID CONDUCTION. ANTI-TACHYCARDIA PACING (ATP) AND FOUR SHOCK WERE DELIVERED, BUT THE RATE GRADUALLY SLOWED ON ITS OWN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS NOTED RESPIRATORY RATE TREND (RRT) OVERSENSING AND THAT THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 12749647 ↗
• InjuryOct 22, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE BATTERY WAS DEPLETING RAPIDLY. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686334 ↗
• InjuryOct 19, 2021Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), PRESENTED TO THE EMERGENCY ROOM AFTER GETTING SHOCKS FOR SINUS TACHYCARDIA. REVIEW OF A CONSULT TRANSMISSION EXHIBITED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO ATRIAL DRIVEN TACHYCARDIA EPISODES, WITH THERAPY EXHAUSTION OBSERVED IN AN EPISODE. TECHNICAL SERVICES (TS) ALSO NOTED DEVICE BATTERY STATUS HAD REACHED ELECTIVE REPLACEMENT INDICATOR, AND RECOMMENDED REPLACING DEVICE WITHIN 90 DAYS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED, PRODUCT ANALYSIS WILL BE COMPLETED, AND THIS REPORT WILL BE UPDATED WITH PERTINENT INFORMATION.

  Patient problems: Electric Shock

  MAUDE report 12662468 ↗
• InjuryOct 19, 2021Premature Discharge of Battery; Interrogation Problem; Premature Discharge of Battery; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO INTERROGATE USING A WAND AND THERE WAS NO MAGNET TONES. THE HEALTHCARE PROFESSIONAL (HCP) TRIED TO INTERROGATE MULTIPLE TIMES WITHOUT SUCCESS. THE CONSULT MESSAGE INDICATED THE DEVICE DATA FAILED. THE ICD WAS INTERROGATED WITH A PROGRAMMER, AND REVEALED THE BATTERY CAPACITY WAS DEPLETED. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION AS 24 MONTHS REMAINING WAS INDICATED DURING LAST DEVICE CHECK IN JANUARY OF LAST YEAR. SUBSEQUENTLY, THE ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE OF A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE IS RECEIVED, THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661275 ↗
• InjuryOct 12, 2021Adverse 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 EXPERIENCED AN INFECTION. SUBSEQUENTLY, THE ICD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 12620479 ↗
• MalfunctionSep 22, 2021High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RIGHT ATRIAL PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS, INAPPROPRIATE ATRIAL TACHY RESPONSE EPISODES AND OVERSENSING OF THE MINUTE VENTILATION FEATURE. THE RESPIRATORY RATE TREND SENSOR WAS PROGRAMMED OFF AND THE NOISE DISAPPEARED. IT WAS NOTED THAT THE ICD IS AT ELECTIVE REPLACEMENT INDICATOR AND THAT THE DEVICE WILL BE EXPLANTED IN THE FUTURE. CURRENTLY, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515790 ↗

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-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-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