DYNAGEN™ CRT-D G151Recalls & reported problems

Summary

The FDA's MAUDE database contains 533 adverse event reports that list this exact device (DI 00802526534638), received between Apr 22, 2016 and Sep 15, 2026 — classified as 3 deaths, 288 injuries, 242 malfunctions.

The most frequently reported specific device problem is “High impedance” (169 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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 533 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the defibrillation of this cardiac resynchronization therapy defibrillator was turned off. The patient is coordinating with the clinic. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775491 ↗
• MalfunctionSep 10, 2026Failure to Capture; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722421 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) had an infection. Upon operation, the device pocket was with erythema, hematoma and reddish capsule. A revision was performed and the CRT-D with the right ventricular (RV) lead, right atrial (RA) lead and left ventricular (LV) lead were explanted. A previously capped LV lead remains capped. Subsequently, antibiotic irrigation of the areas was performed. No additional adverse patient effects were reported. The device was not returned for analysis.

  Patient problems: Erythema; Hematoma; Unspecified Infection

  MAUDE report 50368213 ↗
• MalfunctionJul 30, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50091730 ↗
• MalfunctionJul 1, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS., ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) CONFIRMED THIS REPRESENTS A SUDDEN INCREASE. TS RECOMMENDED REPROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT IT IS PLANNED TO EVALUATE THE PATIENT IN SIX MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678066 ↗
• MalfunctionJun 25, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED REVIEW OF THE DEVICE DATA DUE TO CONCERNS FOR POSSIBLE LEFT VENTRICULAR (LV) LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED THE RECENT PRESENTING ELECTROGRAM (EGM) AND DETERMINED IT APPEARED CONSISTENT WITH LV LOC. THE HCP INDICATED THAT THE PATIENT WOULD BE BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631396 ↗
• MalfunctionJun 25, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED OVERSENSED NOISE ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD, RESULTING IN THE INAPPROPRIATE STORAGE OF ATRIAL TACHY RESPONSE (ATR) EPISODES. ADDITIONALLY, WITHIN-RANGE FLUCTUATIONS IN RA IMPEDANCE MEASUREMENTS WERE OBSERVED. TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING A LEAD EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621301 ↗
• MalfunctionJun 11, 2026Signal Artifact/Noise; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD. SUBSEQUENTLY, ATRIAL SENSITIVITY WAS ADJUSTED TO A LESS SENSITIVE SETTING, AFTER WHICH UNDERSENSING WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25478181 ↗
• MalfunctionJun 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ONE INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR AN ATRIAL DRIVEN RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED THE REPORTS WITH THE CLINICIAN. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25476596 ↗
• MalfunctionJun 11, 2026Failure to Capture

  It was reported that the left ventricular (LV) lead connected to this cardiac resynchronization therapy defibrillator (CRT-D) was suspected to exhibit loss of capture (LOC). It is planned to further evaluate the patient. No adverse patient effects were reported. This device system remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466219 ↗
• MalfunctionMay 15, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE NOISE WAS OVERSENSED. TECHNICAL SERVICES (TS) SUSPECTED THE NOISE WAS ELECTROMAGNETIC INTERFERENCE (EMI) AND RECOMMENDED CONTINUED MONITORING. THIS CRT-D REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186865 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25043213 ↗
• MalfunctionApr 15, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS SYSTEM, WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD, EXHIBITED NOISE ON THE RV CHANNEL, RESULTING IN PACING INHIBITION GREATER THAN 2 SECONDS. TECHNICAL SERVICES (TS) INDICATED THAT IF THE RV LEAD WAS DEMONSTRATING ADVISORY BEHAVIOR, THE RECOMMENDED OPTIONS INCLUDE PROGRAMMING THE DEVICE TO ELECTROCAUTERY MODE OR REPLACING THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 24887459 ↗
• InjuryMar 26, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ACCELERATED THE PATIENTS RHYTHM FROM VENTRICULAR TACHYCARDIA (VT) TO VENTRICULAR FIBRILLATION (VF). TECHNICAL SERVICES (TS) REVIEWED THE EVENT AND DETERMINED THE DEVICE DID NOT OVERSENSE OR UNDERSENSE ANY SIGNALS AND APPROPRIATELY DETECTED THE PATIENTS VT AND DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR TREATMENT. HOWEVER, THE ATP ACCELERATED THE RHYTHM INTO VF FROM SUSPECTED PACING ON A T WAVE DURING THE DELIVERY OF ATP. A SUBSEQUENT MAX SHOCK WAS DELIVERED AND SUCCESSFULLY CONVERTED THE RHYTHM. TS NOTED NO DISCRIMINATORS ARE TURNED ON FOR THE CRT-D AND RECOMMENDED THE FIELD REPRESENTATIVE DISCUSS FURTHER WITH THE PHYSICIAN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24702760 ↗
• DeathMar 19, 2026Signal Artifact/Noise; Pacing Problem; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPORTED TO HAVE PASSED AWAY ON (B)(6) 2026. AN INITIAL REVIEW INDICATED THE PATIENT HAD FOUR TREATED AND ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA FROM THE DATE OF THEIR PASSING. BOSTON SCIENTIFIC DISCUSSED THESE EPISODES WITH THE FIELD AND CONFIRMED THERE WAS EVIDENCE OF UNDERSENSING OF VENTRICULAR FIBRILLATION (VF), WHICH RESULTED IN INSTANCES OF INAPPROPRIATE PACING. LOW AMPLITUDE MEASUREMENTS WERE ALSO NOTED IN SOME OF THE EPISODES. DUE TO THE TIMING OF THESE EPISODES, IT CANNOT BE RULED OUT THAT UNDERSENSING AND INAPPROPRIATE PACING MAY HAVE DETERIORATED THE PATIENT'S CONDITION, WHICH INEVITABLY LED TO THEIR PASSING. ALL EVIDENCE INDICATES THE CRT-D REMAINS IN SITU AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24646192 ↗
• MalfunctionMar 10, 2026Pacing Problem; Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Failure to Read Input Signal; Under-Sensing; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNDERSENSING OF VENTRICULAR ARRHYTHMIA EPISODES REGISTERED ON THE RIGHT VENTRICULAR (RV) CHANNEL. THIS DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP) WHICH DID NOT CONVERT THE RHYTHM AND NO SHOCK THERAPY WAS DELIVERED AS THE DEVICE DID NOT APPROPRIATELY SENSE THE RHYTHM. DURING ONE OF THESE EPISODES, AN ATRIAL PACE RATE OF 33 BEATS PER MINUTE (BPM) WAS RECORDED. ADDITIONALLY, DURING STORED VENTRICULAR EPISODES, THIS DEVICE DISPLAYED AN ISOELECTRIC LINE ON THE RIGHT ATRIAL (RA) CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565021 ↗
• MalfunctionMar 5, 2026Signal Artifact/Noise; High impedance; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN THE RIGHT VENTRICULAR (RV) CHANNEL HIGHER THAN 200 OHMS, AND LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS IN THE RIGHT ATRIAL (RA) CHANNEL LOWER THAN 200 OHMS. ADDITIONALLY, IT WAS NOTED THAT THERE WAS NOISE AND THAT THE INSULATION WAS LIKELY DAMAGED IN THE RA LEAD. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527327 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24388586 ↗
• MalfunctionFeb 10, 2026Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD, MEASURING FOUR OHMS. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING OPTIONS, A CHEST X-RAY, AND DEFIBRILLATION THRESHOLD (DFT) TESTING TO EVALUATE THIS DEVICE SYSTEM. A CHEST X-RAY WAS PERFORMED, AND NO ANOMALIES WERE IDENTIFIED. IT WAS NOTED THAT THE PATIENT WITH THIS DEVICE SYSTEM WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307289 ↗
• MalfunctionJan 29, 2026Premature Discharge of Battery; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1003 BATTERY VOLTAGE ALERT, INDICATING BATTERY VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES (TS) EVALUATED THE EVENT AND DETERMINED THAT THE ALERT WAS A FALSE POSITIVE, TRIGGERED BY AN ABRUPT INCREASE IN RIGHT VENTRICULAR (RV) PACING OUTPUT TO MAXIMUM SETTINGS DUE TO LOSS OF CAPTURE AND HIGH CAPTURE THRESHOLDS IN A PACER-DEPENDENT PATIENT. TS EXPLAINED THAT THE INCREASED POWER CONSUMPTION RESULTED IN A TRANSIENT DROP IN BATTERY VOLTAGE, ACCELERATING THE PROJECTED LONGEVITY TO LESS THAN THREE MONTHS. TS RECOMMENDED CONTINUED MONITORING AS THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATION (ERI) BATTERY STATUS AND DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218179 ↗
• MalfunctionJan 22, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF NOISY SIGNALS THAT RESULTED IN FALSE SIGNAL ARTIFACT MONITOR (SAM) EVENTS. TECHNICAL SERVICES (TS) SUSPECTED THE NOISY SIGNALS WERE DUE TO A PROCEDURE. THE PRESENTING ELECTROGRAM (EGM) AND ALL LEAD MEASUREMENTS SHOWED THE DEVICE OPERATED AS PROGRAMMED. IT WAS NOTED THE CLINICIAN RESOLVED THE EVENT AFTER SPEAKING TO A COLLEAGUE. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148863 ↗
• InjuryJan 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR WHAT APPEARED TO BE SUPRAVENTRICULAR TACHYCARDIA (SVT). TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS WITH THE FIELD REPRESENTATIVE. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24119422 ↗
• MalfunctionJan 8, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS HIGHER THAN 3000OHMS IN THE RIGHT ATRIAL (RA) CHANNEL. TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE DATA. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003822 ↗
• MalfunctionNov 13, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING OF THE ATRIAL EVENTS IN THE LV CHANNEL. THIS CAUSED A DECREASE IN THE LV PACING PERCENTAGE AND PACING INHIBITION. TECHNICAL SERVICES (TS) RECOMMENDED TURNING LV SENSING OFF AND TO BRING IN THE PATIENT TO ENSURE LEAD MEASUREMENTS WERE IN RANGE. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544387 ↗
• InjuryOct 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND CHARGE TIME WAS 14.6 SECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT STATED THAT A COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) ANOMALY NOTED. THIS CRT-D WAS EXPLANTED AND REPLACED WITH THE SAME MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.