VIGILANT X4 CRT-DRecalls & reported problems across all models

We found 2 models of VIGILANT X4 CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,077 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2017 and Sep 29, 2026 — classified as 17 deaths, 1,203 injuries, 857 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (447 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 VIGILANT X4 CRT-D problems

VIGILANT X4 CRT-D models

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

• VIGILANT™ X4 CRT-D G247

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  17 deaths2,066 reports
• VIGILANT™ X4 CRT-D G248

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

Recent VIGILANT 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.

• 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 ↗

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