DYNAGEN™ X4 CRT-D G158Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,166 adverse event reports that list this exact device (DI 00802526534904), received between Apr 21, 2016 and Sep 30, 2026 — classified as 13 deaths, 682 injuries, 471 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (238 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 1,166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947595 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the tachy therapy of this cardiac resynchronization therapy defibrillator was turned off as part of comfort care measures per physician. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Discomfort

  MAUDE report 50774310 ↗
• InjurySep 9, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the health care professional (HCP) called Technical Services (TS) to review the reports for this cardiac resynchronization therapy defibrillator (CRT-D). TS reviewed the data and discussed this CRT-D delivered four anti-tachycardia pacing (ATP) and four shocks for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). TS recommended following up with cardiology. No additional adverse patient effects were reported. This CRT-D remains in service.Additional information was received and it was reported that this CRT-D was reprogrammed and changes were made to medications. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50690741 ↗
• MalfunctionSep 8, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50678896 ↗
• MalfunctionSep 4, 2026Over-Sensing; Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50602249 ↗
• MalfunctionSep 4, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602151 ↗
• InjurySep 4, 2026Defibrillation/Stimulation Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered anti-tachycardia pacing (ATP) and four electrode shocks for two ventricular arrythmia episodes. In both episodes, the ventricular rate accelerated after the first shock was delivered. The rhythm was converted with the second shock in both episodes. This CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: Tachycardia

  MAUDE report 50602111 ↗
• InjurySep 2, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50575369 ↗
• MalfunctionAug 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379056 ↗
• MalfunctionAug 19, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326263 ↗
• InjuryAug 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. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50274597 ↗
• InjuryAug 12, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and right ventricular (RV) lead exhibited oversensing, resulting in pacing inhibition for five seconds. Additionally, inappropriate anti-tachycardia pacing (ATP) therapy and one shock were delivered. It was noted that the company representative planned to follow up with the patient for further investigation. This product remains in service. No adverse patient effects were reported.

  Patient problems: Asystole; Shock from Patient Lead(s)

  MAUDE report 50225930 ↗
• InjuryAug 12, 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 50219651 ↗
• MalfunctionAug 11, 2026Low impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and right ventricular (RV) lead exhibited pacing impedance measurements low out of range. Technical Services (TS) noted this finding while programing the CRT-D into magnetic resonance imaging (MRI) protection mode; however, no programing was performed. TS recommended further review. This product remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213596 ↗
• MalfunctionAug 11, 2026Premature Discharge of Battery; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209689 ↗
• InjuryAug 10, 2026Under-Sensing

  It was reported that patient with this cardiac resynchronization therapy defibrillator (CRT-D) device was seen that the right ventricular (RV) pace after Premature Ventricular Contraction (PVC) by the Health Care Provider (HCP). Boston Scientific technical services reviewed the presenting rhythm and noted that the patient was having PVC's that were falling into cross chamber blanking and sensor was pacing as well and so technical services explained that this was called a functional under sensing. Furthermore, an additional information indicated that this device was explanted. No additional adverse patient effects were reported. The device was returned for analysis.

  Patient problems: Insufficient Information

  MAUDE report 50190467 ↗
• MalfunctionAug 6, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158046 ↗
• InjuryJul 30, 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 50087655 ↗
• InjuryJul 28, 2026Pacing Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a syncopal event. Boston Scientific Technical Services (TS) was consulted and upon review, it was noted that this device stored several pacemaker mediated tachycardia (PMT) episodes, however, these did not correlate to the timing of the syncopal event. Lead measurements were noted to be within range. Further information from the field representative confirmed the syncopal event was not device related, however, the cause of the event has not been determined. No additional adverse patient effects were reported. At this time, this device system remains in service.Additional information was received that this device was explanted due to unknown reasons. No additional adverse patient effects were reported. This device has been received for analysis.

  Patient problems: Syncope/Fainting

  MAUDE report 50063755 ↗
• InjuryJul 28, 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 and erosion. Reportedly, the patient experienced discomfort, pain, edema, inflammation, swelling and fluid discharge. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Discomfort; Erosion; Fluid Discharge; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50059093 ↗
• MalfunctionJul 18, 2026Low impedance; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864860 ↗
• MalfunctionJul 18, 2026Signal Artifact/Noise; Over-Sensing; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864790 ↗
• MalfunctionJul 13, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED USING A PROGRAMMER. TECHNICAL SERVICES (TS) WAS CONSULTED AND TROUBLESHOOTING WAS PERFORMED BUT IT WAS UNSUCCESSFUL. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25806699 ↗
• InjuryJul 7, 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 25733102 ↗
• InjuryJun 30, 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: Bacterial Infection; Unspecified Infection

  MAUDE report 25673911 ↗

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-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-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-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-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-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-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-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.