DYNAGEN™ CRT-D G150Recalls & reported problems

Summary

The FDA's MAUDE database contains 410 adverse event reports that list this exact device (DI 00802526534614), received between Apr 25, 2016 and Sep 10, 2026 — classified as 2 deaths, 251 injuries, 157 malfunctions.

The most frequently reported specific device problem is “High impedance” (118 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 410 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50703251 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) regarding this cardiac resynchronization therapy defibrillator (CRT-D) system. The HCP noted this CRT-D had recently been explanted due to unknown reasons, however part of the lead was broken during the explant procedure and left behind. The HCP was asking TS about magnetic resonance imaging (MRI). TS discussed any fractured or broken lead would be non-conditional. No additional adverse patient effects were reported. This CRT-D has not been returned for analysis.Additional information was received and it was reported that this CRT-D was explanted due to a vegetation on the right ventricular (RV) lead. No additional adverse patient effects were reported. This CRT-D has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690740 ↗
• InjurySep 4, 2026Failure to Read Input Signal; Under-Sensing

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) was evaluated on an in-clinic visit. An issue with the Non-Boston Scientific left ventricular (LV) and right atrial (RA) leads was identified, and the device was subsequently reprogrammed for right ventricular (RV) only. Technical Services (TS) reviewed the presenting electrogram (EGM) and determined that the device was undersensing P waves. TS recommended reprogramming options. No adverse patient effects were reported. This CRT-P remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616744 ↗
• InjurySep 4, 2026Failure to Convert Rhythm; Unexpected Therapeutic Results

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a sudden cardiac arrest (SCA). It was noted that all programmed therapy was exhausted during the event. Technical Services (TS) was consulted, and it was reported that the local company representative planned to perform a Consult transmission to obtain the stored episodes for further review. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest

  MAUDE report 50602083 ↗
• MalfunctionSep 3, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  Patient problems: Bradycardia

  MAUDE report 50599380 ↗
• MalfunctionAug 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Device Sensing Problem

  Patient problems: Asystole

  MAUDE report 50132777 ↗
• MalfunctionJul 2, 2026Failure to Capture; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED A SUDDEN RISE ON PACING IMPEDANCE MEASUREMENTS, REACHING HIGH OUT OF RANGE VALUES GREATER THAN 3000 OHMS ON THE LEFT VENTRICULAR (LV) CHANNEL. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING ENHANCEMENTS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700154 ↗
• InjuryMay 13, 2026Signal Artifact/Noise; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO A PRODUCT PERFORMANCE ANOMALY. THIS CRTD HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE REASON FOR EXPLANTING AND REPLACING THIS CRTD WAS DUE TO NOISE PRESENT IN THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166397 ↗
• MalfunctionApr 17, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON ITS NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORE DATA AS WELL AS PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913609 ↗
• InjuryApr 17, 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. REPORTEDLY, THE IMPLANTABLE LEADS HAD VEGETATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24909250 ↗
• InjuryMar 11, 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 24575548 ↗
• InjuryFeb 27, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE OVERSENSING AND PACING IMPEDANCES LOW OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND STATED THIS WAS LIKELY DUE TO A LEAD ANOMALY. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471420 ↗
• MalfunctionJan 26, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS EXHIBITED SPIKES IN IMPEDANCE. TECHNICAL SERVICES (TS) DISCUSSED A POSSIBLE SPRING CONTACT ISSUE. TS REVIEWED THE ELECTROGRAM (EGM) WITH THE CALLER AND FOUND THIS CRT-D WAS OVERSENSING NOISY SIGNALS ON THE RA AND RV CHANNELS. ALSO, IT WAS NOTED THERE WAS NO PACING INHIBITION GREATER THAN TWO SECONDS. TS RECOMMENDED CONFIGURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AND NON-PHYSIOLOGIC SIGNAL ALERTS IN NXT TO DETECT NOISE IF IT BECAME MORE PROMINENT. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183513 ↗
• InjuryJan 9, 2026Over-Sensing; Pacing Problem; Use of Device Problem; Data Problem

  IT WAS REPORTED THAT THIS PATIENT WAS UNDERGOING AN ABLATION PROCEDURE AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED INTO MRI PROTECTION MODE INSTEAD OF ELECTROCAUTERY PROTECTION MODE. DURING THE ABLATION, PACING WAS INHIBITED FOR THE PATIENT DUE TO OVERSENSING OF THE PULSE FIELD ENERGY FROM THE ABLATION DEVICE. THERE WAS PACING INHIBITION GREATER THAN 2 SECONDS WITH ASYSTOLE. THE PATIENT RHYTHM RETURNED WHEN ABLATION WAS PAUSED. TO CONTINUE THE ABLATION PROCEDURE AN ELECTROPHYSIOLOGY (EP) CATHETER WAS USED TO PACE. THIS EP CATHETER WAS PLACED IN THE VENOUS ACCESS INTO THE APEX OF THE RIGHT VENTRICLE. THE ABLATION PROCEDURE WAS COMPLETED AND THE CRT-D WAS OPERATING AS NORMAL AFTERWARDS. ALL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL LIMITS. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 24027612 ↗
• InjuryJan 9, 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. REPORTEDLY, THE CRT-D WAS USED AS A TEMPORARY PACING SYSTEM. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24016887 ↗
• InjuryJan 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED SEVERAL INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPIES AND INAPPROPRIATE SHOCKS TRIGGERED BY ATRIAL ACTIVITY. AS A RESULT, ALL AVAILABLE THERAPIES WERE EXHAUSTED. DEVICE EVALUATION CONFIRMED THAT THE CRT-D WAS FUNCTIONING AS PROGRAMMED, AND PROGRAMMING ADJUSTMENTS WILL BE CONSIDERED. THE PRODUCT REMAINS IN SERVICE, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23994338 ↗
• InjuryDec 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A PROCEDURE TO REPLACE THE RIGHT VENTRICULAR (RV) LEAD IN THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE RIGHT ATRIAL (RA) LEAD AND CRT-D WERE EXPLANTED AND REPLACED DUE TO HIGH PACING IMPEDANCE MEASUREMENTS. AT THIS TIME, THIS CRT-D HAS NOT BEEN RETURNED FOR ANALYSIS, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898105 ↗
• MalfunctionDec 4, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE OVERSENSING AND HIGH PACING IMPEDANCES OUT OF RANGE ON THE RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND STATED THIS WAS LIKELY DUE TO A SPRING CONTACT ISSUE. TS RECOMMENDED TO HAVE LEAD EVALUATION. IT WAS NOTED THAT THE RA LEAD IS NOT A BOSTON SCIENTIFIC PRODUCT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723190 ↗
• MalfunctionNov 13, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS 8 YEARS REMAINING AND PATIENT THINKS THE BATTERY DROPS 2 YEARS IN A SPAN OF 3 MONTHS BASED ON THE REPORT FROM THE MONITORING COMPANY. THE PATIENT WANTED TO FIGURE OUT OF WHAT IS GOING ON WITH THE DEVICE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550145 ↗
• InjuryOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM DEMONSTRATED A NOTABLE DECREASE IN IMPEDANCE COMPARED TO THE LAST IN CLINIC EVALUATION. A BREAKDOWN OF THE DEFIBRILLATION VECTORS INDICATED DIRECTIONAL CHANGES CONSISTENT WITH EVOLVING LEAD CHARACTERISTICS. TECHNICAL SERVICES REVIEWED HISTORICAL SYSTEM DATA AND IDENTIFIED A GRADUAL UPWARD TREND IN BASELINE IN SHOCK LEAD IMPEDANCE OVER SEVERAL YEARS. BASED ON THE VECTOR PATTERNS AND IMPEDANCE TRENDS, THE FINDINGS SUGGEST SIGNIFICANT CALCIFICATION OF THE PROXIMAL COIL RELATIVE TO THE DISTAL COIL. A DEFIBRILLATION THRESHOLD TEST (DFT) SHOULD BE CONSIDERED TO ENSURE THE SYSTEM REMAINS EFFECTIVE IN A SINGLE COIL CONFIGURATION. THE HEALTHCARE PROVIDER ACKNOWLEDGED AND UNDERSTOOD THE RECOMMENDATION. THIS DEVICE REMAINS IN SERVICE. THIS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT INVESTIGATION DETERMINED THAT THE "KNOWN INHERENT RISK OF DEVICE" INVESTIGATION CONCLUSION CODE WAS SELECTED BASED ON PRODUCT RECORD AND REPORTED OBSERVATION REVIEW. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-D WAS EXPLANTED AND RETURNED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIEN

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 23359652 ↗
• MalfunctionOct 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS FOR ITS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336583 ↗
• InjuryOct 16, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STORED VENTRICULAR EPISODES TO CONFIRM DEVICE OPERATION. IT WAS NOTED THAT THE PATIENT WAS IN AN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) ARRHYTHMIA. UPON REVIEW, THE VENTRICULAR EPISODES HAD RECORDED DELIVERY OF ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPIES. IT WAS DETERMINED THAT THE DEVICE HAD INAPPROPRIATELY DELIVERED THE THERAPY. THE THERAPY WAS EXHAUSTED. TS DISCUSSED PROGRAMMING OPTIONS WITH THE HCP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE CRT-D REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23316977 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 POCKET INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23308569 ↗
• InjuryJul 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A CODE 1007 INDICATIVE OF CHARGE TIME EXCEEDING LIMITATIONS ALONG WITH THE EXPLANT INDICATOR BEING DECLARED. THE DATES THAT WERE PROVIDED FOR CODE 1007 AND THE EXPLANT INDICATOR WERE MISMATCHED. TECHNICAL SERVICES RECOMMENDED THE DEVICE BE REMOVED AND REPLACED. AT THIS TIME, THE DEVICE HAS BEEN EXPLANTED. ANOTHER DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THIS CRT-D HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED BESIDES THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679303 ↗
• MalfunctionJul 16, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING A VISIT, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO HAVE STORED PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODES. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THE PMT EVENT. UPON REVIEW, THE PRESENTING ELECTROGRAM (EGM) SHOWED THAT THE PMT EVENT APPEARED TO EXHIBIT T WAVE OVERSENSING AND PACING INHIBITION. TS DISCUSSED PROGRAMMING OPTIMIZATION OPTIONS WITH THE HCP. AT THIS TIME, THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 22523182 ↗

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-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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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-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-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-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-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-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.