INCEPTA™ ICD E162Recalls & reported problems

Summary

The FDA's MAUDE database contains 570 adverse event reports that list this exact device (DI 00802526480775), received between Jul 30, 2013 and Sep 4, 2026 — classified as 426 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (254 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 570 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602345 ↗
• MalfunctionAug 19, 2026Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was suspected of premature battery depletion (PBD) as the battery has depleted from 7 months down to reaching Elective Replacement Indicator state. The Boston Scientific Technical Services consultant evaluated the transmission data which demonstrated a charge time of 15.7 seconds, representing a secondary criterion for recommending a device replacement while the system continues to operate normally. Subsequently, this ICD was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50313817 ↗
• InjuryAug 5, 2026Insufficient Device Problem Information

  It was reported that the battery of this implantable cardioverter defibrillator (ICD) reached a completely depleted state beyond End of Life (EOL). Technical Services (TS) assessed the device and indicated that sinus bradycardia and ejection fraction (EF) of 20 percent were listed as the implant indications. To date, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150340 ↗
• InjuryJul 6, 2026Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT-OF-RANGE RIGHT ATRIAL LEAD IMPEDANCES, WITH THE FIRST LOW IMPEDANCE DETECTED SHORTLY AFTER IMPLANTATION. THE CURRENT DEVICE ALSO REPORTED AN OUT-OF-RANGE ATRIAL PACING LEAD IMPEDANCE. FINDINGS WERE CONSISTENT WITH AN ATRIAL LEAD INSULATION BREACH ASSOCIATED WITH NOISE ON THE RA LEAD. THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO UPGRADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728151 ↗
• InjuryJun 18, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOLLOWING A SYNCOPAL EVENT. DEVICE INTERROGATION INDICATED THAT ATRIAL PACING IMPEDANCE ON THE ATRIAL CHANNEL WAS GREATER THAN 2500 OHMS. THE ATRIAL LEAD IS MANUFACTURED BY A THIRD-PARTY (NON-BOSTON SCIENTIFIC) MANUFACTURER. NO ARRHYTHMIC EPISODES WERE RECORDED WITHIN THE DEVICE'S PROGRAMMED DATA COLLECTION PERIOD THAT WOULD CORRELATE WITH THE REPORTED SYNCOPAL EVENT. REVIEW OF THE PRESENTING ELECTROGRAM (EGM) DEMONSTRATED THAT THE DEVICE WAS OPERATING AS PROGRAMMED. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP FOR APPROXIMATELY EIGHT YEARS. THE REPORTED CLINICAL OBSERVATIONS WERE DOCUMENTED. THE SYSTEM REMAINS IN SERVICE, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25550664 ↗
• MalfunctionJun 1, 2026Communication or Transmission Problem; Noise, Audible; Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED TECHNICAL SERVICES (TS) AND IT WAS SUSPECTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SINCE IT HAD BEEN IMPLANTED FOR OVER 10 YEARS. HOWEVER, DUE TO NO INFORMATION OF THIS PATIENT ON LATITUDE NXT, THIS COULD NOT BE CONFIRMED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356320 ↗
• MalfunctionMar 30, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A RED CALL DOCTOR DUE TO SHOCK IMPEDANCE OUT OF RANGE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729275 ↗
• InjuryMar 30, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24712699 ↗
• InjuryMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND ANOTHER DEVICE WAS IMPLANTED SUCCESSFULLY. THIS ICD HAS BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581326 ↗
• InjuryMar 11, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED LOW OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS MEASURING LESS THAN 200 OHMS. TESTING WAS PERFORMED AND IMPEDANCES MEASURED 230 OHMS. A REVIEW OF A STORED EVENT HAD OBSERVATIONS OF NOISE THAT WAS BEING OVERSENSED ON ALL THREE CHANNELS AND WAS SUSPECTED IT WAS DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). A REVIEW OF LEAD TRENDING APPEARS STABLE MEASURING AROUND 200-300 OHMS. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569180 ↗
• MalfunctionFeb 16, 2026Pacing Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED A BATTERY STATUS INDICATOR OF EXPLANT. THE BATTERY STATUS A 6 DAYS PREVIOUS INDICATED 9 MONTHS REMAINING TO EXPLANT. THE EXPLANT INDICATOR WAS FOUND TO BE DUE TO EXTENDED CHARGE TIMES. DATA ANALYSIS CONFIRMED THAT THE POWER CONSUMPTION IS NORMAL AND CHARGE TIMES INCREASED NORMALLY. THERE WERE MULTIPLE CHARGES THAT OCCURRED ON 02 FEBRUARY AND THEN AN INTERROGATION ON 06 FEBRUARY. A NORMAL REPLACEMENT INTERVAL IS EXPECTED. IN ADDITION, IT WAS NOTED THAT THE PATIENT EXPERIENCED A SYNCOPE EPISODE RELATED TO MULTIPLE EPISODES OF VENTRICULAR ARRYTHMIA AND TWO SHOCKS WERE APPROPRIATELY DELIVERED. DEVICE APPEARS TO BE FUNCTIONING AS PROGRAMMED. CURRENTLY, EVIDENCE SUGGESTS THAT THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 24345687 ↗
• InjuryFeb 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 10 BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND 2 SHOCKS AS INAPPROPRIATE THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA (SVT). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. TS NOTED HOW THE DEVICE HAD HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, WITH THE RISE BEEN GRADUAL. TS DISCUSSED THERAPY DELIVERY EFFECTIVENESS BASED ON CURRENT MEASUREMENTS, WITH LEAD REPLACEMENT RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24304766 ↗
• InjuryJan 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVERAL ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS IN THE SPAN OF EIGHT EPISODES OF WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED POSSIBLE REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24222019 ↗
• MalfunctionJan 28, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED THAT THE IMPEDANCE MEASUREMENT WAS 125 OHMS. TS SUGGESTED TO CONTINUE MONITORING THE RV LEAD AND INCREASING THE IMPEDANCE ALERT TO 150 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203032 ↗
• MalfunctionJan 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FELT IMPLANT WAS DIFFERENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106759 ↗
• InjuryJan 5, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ONE INAPPROPRIATE SHOCK DUE TO OVERSENSING FROM AN ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE. IT WAS NOTED THAT THE SOURCE WAS A MICROCURRENT FACIAL MUSCLE STIMULATOR THE PATIENT HAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED HOW TO PROGRAM BEEPING DURING CAPACITOR CHARGE FOR THIS DEVICE, AS WELL AS ADVICE THE PATIENT TO USE A DIFFERENT DEVICE THAT HAD NO ISSUES PREVIOUSLY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23957769 ↗
• InjuryDec 2, 2025Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD LESS THAN THREE MONTHS LEFT THEREFORE, THE PHYSICIAN DECIDED TO REPLACE IT WHILE REPLACING THE RV LEAD. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694764 ↗
• MalfunctionDec 1, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS ICD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT, GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) DISCUSSED REPLACING THIS ICD AND THE RV LEAD. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688534 ↗
• InjuryOct 20, 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. TECHNICAL SERVICES REFERRED THE HEALTH CARE PROFESSIONAL TO CARDIOLOGY FOR ADDITIONAL REVIEW. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23335679 ↗
• InjuryOct 8, 2025Signal Artifact/Noise; Failure to Capture; Low impedance; Signal Artifact/Noise; Failure to Capture; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE THAT RESULTED IN FALSE ATRIAL TACHY RESPONSE (ATR) EPISODES ON THE RIGHT ATRIAL (RA) CHANNEL. IT WAS ALSO NOTED THAT THERE WAS INTERMITTENT OR TOTAL LOSS OF CAPTURE AND A SINGULAR DROP IN IMPEDANCE MEASUREMENTS, WHICH REMAINED IN RANGE. THIS ICD SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23244040 ↗
• InjurySep 18, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23090573 ↗
• InjurySep 15, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED EPISODES. UPON REVIEW THE PRESENTING ELECTROGRAM (EGM) SHOWED THAT THE PATIENT WAS IN A VENTRICULAR FIBRILLATION (VF) EPISODE. THE DEVICE DELIVERED A SHOCK, HOWEVER, DURING THE SHOCK DELIVERY, CODE 1005 WHICH INDICATED AN OPEN CIRCUIT CONDITION WAS RECORDED. THE CAUSE OF THE CODE 1005 WAS DETERMINED TO BE DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD WERE RECORDED DURING THE SHOCK DELIVERY. THE SHOCK WAS ABLE TO SUCCESSFULLY CONVERT THE ARRHYTHMIA. TS RECOMMENDED FOR THE REPLACEMENT OF THE DEVICE AND RV LEAD. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053285 ↗
• MalfunctionSep 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SHOCK LEAD IMPEDANCE HIGH OUT OF RANGE. THE SYSTEM HAS BEEN IN SERVICE FOR OVER 12 YEARS AND IS NOW AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED, THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044921 ↗
• MalfunctionAug 27, 2025Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal; Under-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Failure to Read Input Signal; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE OVERSENSING AS WELL AS ALERTS FOR INTRINSIC AMPLITUDE OUT OF RANGE WITH UNDER SENSING ON BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CHANNELS. IT WAS ALSO NOTED THAT A DECREASE IN SHOCK IMPEDANCE MEASUREMENTS FROM 70 OHMS TO 49 OHMS OCCURRED. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW IT WAS MENTIONED THAT THE NOISE COULD BE RELATED TO CAUTERY NOISE DURING A MEDICAL PROCEDURE, HOWEVER FURTHER IN OFFICE EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE OBSERVATIONS WAS A CARDIOVERSION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906291 ↗
• MalfunctionJul 30, 2025Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED SUPRAVENTRICULAR TACHYCARDIA (SVT) EPISODES. UPON REVIEW, IT WAS OBSERVED THAT THE ICD HAD DELIVERED INAPPROPRIATE SHOCK DUE TO ATRIAL UNDERSENSING. TS DISCUSSED PROGRAMMING OPTIMIZATION OPTIONS WITH THE ICD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD AND RIGHT ATRIAL (RA) LEAD REMAIN IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22666817 ↗

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