DYNAGEN X4 CRT-DRecalls & reported problems across all models

We found 2 models of DYNAGEN X4 CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,545 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 30, 2026 — classified as 20 deaths, 894 injuries, 631 malfunctions.

The most frequently reported specific device problem is “High impedance” (334 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DYNAGEN X4 CRT-D problems

DYNAGEN X4 CRT-D models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DYNAGEN™ X4 CRT-D G158

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  13 deaths1,166 reports
• DYNAGEN™ X4 CRT-D G156

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  7 deaths379 reports

Recent DYNAGEN X4 CRT-D adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 30, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range shock impedance measurements. Technical Services (TS) was consulted and confirmed out of range measurements. TS noted that the system was reprogramming to a different vector with measurements that were within range. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945279 ↗
• 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 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; High impedance; Data Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system was interrogated with a programmer that had an inaccurate date and time group. TS discussed the programmer would need to be evaluated to resolve this. It was also noted this CRT-D system exhibited high out of range pacing impedance measurements on the right atrial (RA) lead. Technical Services (TS) noted the Atrial Tachy Response (ATR) episode showed non-physiologic noise and discussed it was probable early signs of a lead fracture. It was also noted the patient reported not feeling well recently. The patient was scheduled for an in-clinic interrogation to synch the programmer with the accurate date and time. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Discomfort

  MAUDE report 50715895 ↗
• 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 ↗

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