VIGILANT™ X4 CRT-D G247Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,066 adverse event reports that list this exact device (DI 00802526589287), received between Oct 9, 2017 and Sep 29, 2026 — classified as 17 deaths, 1,196 injuries, 853 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (447 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 2,066 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941321 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50939924 ↗
• MalfunctionSep 28, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925280 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50918694 ↗
• MalfunctionSep 25, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906311 ↗
• InjurySep 24, 2026Failure to Convert Rhythm; Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891923 ↗
• InjurySep 23, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; High Capture Threshold

  Patient problems: Bradycardia; Malaise

  MAUDE report 50876217 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 50829477 ↗
• MalfunctionSep 18, 2026Device Sensing Problem

  It was reported that the patient with this pacemaker experienced more tiredness than before, the patient alleged requiring pacemaker adjustments. Technical Services (TS) was consulted and reviewed possible reasons for the exhibited change, including physiological changes and device optimization options. A temporary interference with sensing was discussed. This pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: Fatigue

  MAUDE report 50818194 ↗
• MalfunctionSep 17, 2026Pacing Problem; Failure to Read Input Signal; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812243 ↗
• MalfunctionSep 17, 2026Battery Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) had reached Elective Replacement Indicator (ERI) since May and may have been beyond End of Life (EOL) at this point. Technical Services (TS) discussed that there is no guarantee of continued device function so device should be replaced urgently. To date, this device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800691 ↗
• InjurySep 16, 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 50784490 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764618 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50738809 ↗
• InjurySep 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered anti-tachycardia pacing (ATP) and shocks due to a suspected atrial originated arrhythmia with rapid ventricular response (RVR) resulting in therapy exhaustion. Additionally, it was inquired whether a shock was delivered on a T wave. Technical Services (TS) reviewed the episode and discussed that the large deflection was not the shock but a deflection of where the sense amplifiers are turned back on. The shock was given at the marker shortly after the QRS complex. TS provided programming recommendations. No additional adverse patient effects were reported. This device remains in service.Additional information was provided indicating that programming parameters were adjusted. No additional adverse patient effects were reported. This device remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50738159 ↗
• InjurySep 10, 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 50710844 ↗
• MalfunctionSep 10, 2026Insufficient Device Problem Information

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a syncope episode and a fall. Technical Services (TS) was consulted and referred the patient to their medical doctor for further review. This device remains in service. No adverse patient effects were reported.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 50708234 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was explanted due to an unknown reason.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50675858 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) exhibited infection. A revision was performed and the CRT-D along with the implantable leads were explanted. No adverse patient effects were reported. The CRT-D will not be returned.

  Patient problems: Unspecified Infection

  MAUDE report 50614373 ↗
• MalfunctionSep 4, 2026Over-Sensing; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602247 ↗
• MalfunctionSep 4, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602168 ↗
• InjurySep 4, 2026Over-Sensing

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a fall. Technical Services (TS) was consulted and noted the presence of far field oversensing of right ventricular (RV) signals on the right atrial (RA) channel, with atrial tachy response (ATR) episodes stored. TS conducted a Heart Connect session with the local company representative, during which sensitivity adjustments were made and the ATR episode criteria settings were modified. This device remains in service. No adverse patient effects were reported.

  Patient problems: Fall

  MAUDE report 50602131 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602114 ↗
• MalfunctionSep 4, 2026Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602058 ↗
• InjuryAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) reverted to Safety Mode. The patient experienced stimulation and received and inappropriate shock. Additionally, the patient felt anxiety. Technical Services (TS) was contacted and after reviewing the data, noted that therapy was turned off. This device was explanted and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Anxiety; Device Overstimulation of Tissue; Shock from Patient Lead(s)

  MAUDE report 50424468 ↗

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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• 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-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-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-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-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-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-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.