DYNAGEN™ EL ICD DR D153Recalls & reported problems

Summary

The FDA's MAUDE database contains 886 adverse event reports that list this exact device (DI 00802526534829), received between Apr 22, 2016 and Sep 28, 2026 — classified as 4 deaths, 394 injuries, 488 malfunctions.

The most frequently reported specific device problem is “High impedance” (351 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. 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 886 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Convert Rhythm; Under-Sensing; Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system required six shocks to convert ventricular fibrillation (VF) and exhibited low shock impedance measurements of 80 Ohms. Additionally, undersensing was also observed. It was noted that the undersensing did not cause the difficulty to convert. The patient was reported to have low potassium levels and to experience acute heart failure which the physician believed contributed to the failed shocks. Technical Services (TS) was contacted and after reviewing the available information, noted that the Ohm range available was sufficient to convert. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916969 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697765 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to an unspecified reason. The physician noted this ICD was explanted due to "ventricular tachycardia (VT)" with no further information available. This ICD was explanted and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Tachycardia

  MAUDE report 50602161 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602060 ↗
• MalfunctionSep 4, 2026Device Alarm System; Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600740 ↗
• MalfunctionAug 24, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421701 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient implanted with this implantable cardioverter defibrillator (ICD) system had a syncopal episode while getting out of the shower, and the patient was admitted to the hospital. Electrogram (EGM) review showed there were stored arrhythmia episode that correlated with the reported syncope. Anti-tachycardia pacing (ATP) and six shocks were delivered, and the rhythm converted. The device was operating as programmed. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Syncope/Fainting

  MAUDE report 50383806 ↗
• InjuryJul 27, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited a product performance issue. The patient underwent a surgical intervention to remove this ICD and implant a new product. No additional adverse patient effects were reported. Additional information was received that this ICD recorded high out of range shock impedance measurements. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024788 ↗
• MalfunctionJul 14, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED ASSISTANCE WITH PROGRAMMING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TS REVIEWED THE DEVICE SETTINGS AND CONFIRMED THAT THE ICD WAS NOT APPROVED OF MRI DUE TO NON-BOSTON SCIENTIFIC LEADS. TS ALSO NOTED THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED CONSISTENT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TS ADVISED IF MRI SCAN IS PERFORMED IT WOULD BE CONSIDERED TO BE OFF LABEL. THE HCP NOTED THE CONSISTENT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS IS KNOWN BY PHYSICIAN AND AN OFF LABEL ORDER WAS SENT. TS ASSISTED WITH PROGRAMMING THE MRI PROTECTION MODE ON. LATER ON, THE MRI PROTECTION MODE WAS PROGRAMMED OFF AND DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD AND NON-BOSTON SCIENTIFIC RA LEAD REMAIN IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820985 ↗
• InjuryJul 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE LAST SHOCK WAS DELIVERED WITH REVERSED POLARITY AND ANALYSIS FROM TECHNICAL SERVICES (TS) NOTED WHEN THE DEVICE IS INTERROGATED, THERE WILL BE A CODE 1005. ENGINEERING GUIDANCE DISCUSSED TO CLEAR THE FAULT AND EVALUATE THE INTEGRITY OF THE DEVICE AND LEAD SYSTEM. IT WAS RECOMMENDED TO CONSIDER LEAD REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25738395 ↗
• InjuryJul 7, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND TWO SHOCKS FOR VENTRICULAR TACHYCARDIA (VT). TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND DETERMINED THE RHYTHM WAS VENTRICULAR DRIVEN BECAUSE THE VENTRICULAR RHYTHM WAS SLIGHTLY FASTER THAN THE ATRIAL RHYTHM. THE ATP BURSTS WERE NOT EFFECTIVE AT BREAKING THE RHYTHM. THE SECOND SHOCK SLOWED THE RHYTHM, BUT TS COULDN'T DETERMINE IF THIS BROKE THE RHYTHM. THE LOGBOOK SHOWED SIMILAR EPISODES STARTING IN (B)(6) 2026. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO THEIR VT. WHEN THE PATIENT WAS INTERROGATED IN THE ER, THE VT HAD BROKEN AND THE PATIENT WAS IN NORMAL SINUS RHYTHM. THE PATIENT WAS PRESCRIBED AMIODORANE AND DISCHARGED. THE PATIENT WAS SCHEDULED TO COME INTO THE CLINIC TO DETERMINE HOW THEY'RE TOLERATING THE MEDICATION AND DETERMINE IF IT HELPED THEIR VT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736757 ↗
• MalfunctionJul 3, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED FOLLOW UP AND PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25704780 ↗
• MalfunctionJul 3, 2026Premature 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. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED THAT POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. 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 25700927 ↗
• InjuryJul 3, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AND HAD LOST HALF OF A YEAR OF DEVICE BATTERY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700921 ↗
• MalfunctionJul 1, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED A SUDDEN HIGH OUT OF RANGE SHOCK IMPEDANCE RISE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED PROGRAMMING ENHANCEMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681180 ↗
• MalfunctionJun 29, 2026Premature 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 CONFIRMED THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661292 ↗
• MalfunctionJun 26, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) SUSPECTED IT WAS DUE TO SPRING CONTACT BEHAVIOR WITH THE LEAD. IT WAS NOTED THIS PATIENT HAS A MEDTRONIC LEAD AND THERE WAS NO NOISE PRESENT. TS RECOMMENDED CONTINUED MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638395 ↗
• MalfunctionJun 26, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING OF NOISY SIGNALS, THAT RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE SHOCKS, ELECTING THE FIELD REPRESENTATIVE TO TURN OFF TACHYCARDIA AND BRADYCARDIA THERAPIES. TECHNICAL SERVICES (TS) WAS NOTIFIED OF THE PLAN TO IMPLANT A COMPETITORS DEVICE AND KEEP THE ICD IMPLANTED; HOWEVER, THERAPY WOULD REMAIN OFF. THE LOCAL FIELD REPRESENTATIVE AND TS DISCUSSED IF THE DEVICE COULD RESET AND TURN THERAPY BACK ON, IN WHICH TS STATED THERE ARE RARE CASES OF THE DEVICE ENTERING SAFETY MODE AND BECOMING ACTIVE AGAIN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 25636471 ↗
• InjuryJun 24, 2026Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT WHILE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DELIVERING ANTI-TACHYCARDIA PACING (ATP) FOR VENTRICULAR FIBRILLATION, AN INAPPROPRIATE SHOCK WAS DELIVERED THAT ACCELERATED THE RHYTHM INTO A SHORT BURST OF VENTRICULAR TACHYCARDIA (VT). TECHNICAL SERVICES (TS) WAS CONSULTED TO REVIEW EPISODES AND CONFIRMED THE INITIAL CONDITION WAS PATIENT RELATED AND THAT ATP WAS HIGHLY SUCCESSFUL. TS NOTED THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK AFTER ATP HAD CONVERTED, CREATING THE SHORT BURST OF VT. TS DETERMINED THAT THERAPY WAS NEVER EXHAUSTED AND GAVE SYSTEM AND PATIENT RELATED RECOMMENDATIONS BASED ON THE EPISODES REVIEWED.

  Patient problems: Tachycardia

  MAUDE report 25610817 ↗
• InjuryJun 12, 2026Pacing Problem; Defibrillation/Stimulation Problem; Under-Sensing

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WHICH STORED A NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE. UPON REVIEW, THERE WAS A VENTRICULAR BEAT THAT WAS BLANKED AND A VENTRICULAR PACE WAS DELIVERED AROUND THE T-WAVE. IT WAS SUSPECTED THAT THE VENTRICULAR PACE CONTRIBUTED TO THE ARRHYTHMIA. IT WAS NOTED THAT A PREMATURE VENTRICULAR CONTRACTION (PVC) ALSO OCCURRED AROUND THE ATRIAL PACE AND MAY HAVE CAUSED THE ARRHYTHMIA AS WELL. OTHER EPISODES WITHOUT THE VENTRICULAR PACING HAD A SIMILAR PATTERN. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 25486758 ↗
• MalfunctionJun 10, 2026Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED POSSIBLE ATRIAL FIBRILLATION EPISODES FOR WHICH THE HEALTHCARE PROFESSIONAL (HCP) REQUESTED ASSESSMENT. THE HCP ALSO CONFIRMED AWARENESS OF LOW P-WAVE AMPLITUDES AND HAVING ADJUSTED VENTRICULAR SENSITIVITY. TECHNICAL DISCUSSION INCLUDED THE POSSIBILITY OF AT/AF EPISODES AS WELL AS INTERMITTENT FAR-FIELD OVERSENSING. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE CONDITION HAD BEEN ONGOING FOR AN EXTENDED PERIOD WITH CONTINUED MONITORING AND MULTIPLE SENSITIVITY ADJUSTMENTS. TROUBLESHOOTING OPTIONS RELATED TO P-WAVE SENSING, SENSITIVITY PROGRAMMING, AND BLANKING PARAMETERS WERE DISCUSSED. THE ISSUE APPEARED TO BE CHRONIC IN NATURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25452715 ↗
• MalfunctionJun 4, 2026Signal Artifact/Noise; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE AND PACING INHIBITION UP TO 2 SECONDS. THE NOISE ALSO LED TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) BEING DELIVERED. THE LEAD PACE IMPEDANCE WAS ALSO NOTED TO BE HIGH OUT OF RANGE. TECHNICAL SERVICES (TS) RECOMMENDED POTENTIAL PROGRAMMING CHANGES FOR THIS LEAD. LEAD REPLACEMENT WAS RECOMMENDED. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25400916 ↗
• MalfunctionJun 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE COMMUNICATOR FOR THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A RED CALL DOCTOR FLASHING LIGHT. AT THIS TIME, THE CAUSE FOR THE ALERT REMAINS UNKNOWN; HOWEVER, IT WAS NOTED THAT THE COMMUNICATOR HAD SENT A DATA UPDATE THE DAY AFTER THE ALLEGATION WHERE NO ALERTS WERE SEEN. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385163 ↗
• MalfunctionMay 20, 2026Premature 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25236944 ↗
• MalfunctionMay 18, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE ON THE RIGHT ATRIAL (RA) CHANNEL. NOISE WAS UNABLE TO BE REPRODUCED IN THE OFFICE AND SENSING; IMPEDANCE AND THRESHOLD VALUES WERE NORMAL. ADDITIONALLY, THERE WAS AN INCREASE IN THE RA RATE COUNT OF 250 PPM. ADDITIONALLY, THERE WAS EVIDENCE OF FARFIELD OVERSENSING RESULTING IN FALSE ATRIAL TACHYCARDIA RESPONSE EPISODE (ATR). TECHNICAL SERVICES (TS) SUGGESTED CONTINUED MONITORING. THIS DEVICE REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198399 ↗

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-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-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-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