VIGILANT™ X4 CRT-D G248Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00802526589300), received between Apr 9, 2018 and Jun 12, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) CHANNEL. THE LOSS OF CAPTURE WAS OBSERVED AFTER THE PATIENT RECEIVED APPROPRIATE SHOCK THERAPY FOR VENTRICULAR TACHYCARDIA (VT). AFTER THE SHOCK, THE DEVICE DELIVERED BIVENTRICULAR (BIV) PACING, AND THE LOSS OF CAPTURE WAS OBSERVED AFTER THE BIV PACING. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue; Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486751 ↗
• MalfunctionMay 21, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING, WITH VENTRICULAR SIGNALS APPEARING ON THE ATRIAL CHANNEL. THIS RESULTED IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING AND REPROGRAMMING OPTIONS, SUCH AS ADJUSTING THE ATRIAL BLANKING PERIOD AFTER VENTRICULAR PACING OR ALTERING THE RIGHT ATRIAL SENSITIVITY. THIS CRTD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365541 ↗
• InjuryJan 5, 2024Signal Artifact/Noise; Failure to Capture; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS SYSTEM WITH A RIGHT VENTRICULAR (RV) LEAD AND A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A RV AUTOMATIC THRESHOLD DETECTED AS GREATER THAN PROGRAMMED AMPLITUDE OR SUSPENDED, ALERT. IT WAS IDENTIFIED THAT THE ALERT WAS RELATED TO HIGH PACING THRESHOLDS WITHOUT SAFETY MARGIN AND LOSS OF CAPTURE (LOC) WAS SUSPECTED. ALSO, IT WAS NOTED THAT THE CRT-D RECORDED TWO FALSE POSITIVE SIGNAL ARTIFACT MONITORING EPISODES DUE TO A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE. IT WAS RECOMMENDED TO BRING THE PATIENT BACK SO THE RESPIRATORY RATE TREND COULD BE TURNED BACK ON AND TO ADJUST THE RV OUTPUTS ACCORDING WITH A BETTER SAFETY MARGIN. THE PATIENT HAD BEEN HAVING SOME INTERMITTENT LIGHTHEADEDNESS. THE RV LEAD REMAINS IN SERVICE AND THE CRT-D HAS BEEN EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness

  MAUDE report 18451834 ↗
• MalfunctionAug 16, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING AN IN-OFFICE VISIT THERE WAS DIFFICULTY INTERROGATING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TROUBLESHOOTING WAS PERFORMED AND A MAGNET WAS PLACED OVER THE DEVICE HOWEVER, THERE WERE NO BEEPING TONES. ANOTHER PROGRAMMER WAS USED, AND THE DEVICE WAS STILL UNABLE TO BE INTERROGATED. IT WAS NOTED THERE WAS A RECENT REMOTE INTERROGATION FROM A FEW DAYS AGO AND ESTIMATED BATTERY LONGEVITY WAS AT FOUR AND A HALF YEARS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555820 ↗
• MalfunctionJan 3, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD AND HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. TROUBLESHOOTING OPTIONS WERE DISCUSSED AND RECOMMENDED. AT THIS TIME, THE CRT-D SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090141 ↗
• InjuryJul 13, 2022High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; Under-Sensing; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; Under-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE DELIVERED SIX SHOCKS RESULTING IN THERAPY EXHAUSTION. THIS PATIENT THEN EXPERIENCED A SYNCOPAL EPISODE IN WHICH THE EMERGENCY MEDICAL TECHNICIAN (EMT) HAD TO PROVIDE THREE EXTERNAL SHOCKS TO SUCCESSFULLY CONVERT THE PATIENT. THIS SYSTEM EXHIBITED HIGH OUT-OF- RANGE SHOCK LEAD IMPEDANCES RESULTING IN A RECORDED CODE 1005. REVIEW OF THE ELECTROGRAM SHOWS THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) IN WHICH THE DEVICE APPROPRIATELY PROVIDED THERAPY. THE RHYTHM GOT SUPER FINE AFTER THE ATP AND WITH SOME UNDERSENSING NOTED. THE PATIENT WAS THEN TRANSPORTED TO THE INTENSIVE CARE UNIT. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIMIZATION. AT THIS TIME, THIS SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 15008018 ↗
• InjuryApr 13, 2021Adverse 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 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 11660740 ↗
• MalfunctionMay 6, 2019High impedance; Over-Sensing; Device Sensing Problem; High impedance; Over-Sensing; Device Sensing Problem

  THIS SUPPLEMENTAL REPORT IS BEING FILED BECAUSE THE CONCLUSION CODE WAS UPDATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581353 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THE SYSTEM WAS EXPLANTED WITHOUT COMPLICATION AND THE EXPLANTED PRODUCTS WERE SENT FOR CULTURE SENSITIVITY TEST. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7727025 ↗
• InjuryJun 28, 2018Failure to Capture; Failure to Sense; Connection Problem; Failure to Capture; Failure to Sense; Connection Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM EXHIBITED LOSS OF SENSING AND CAPTURE ON THE ATRIAL CHANNEL DUE TO WHAT APPEARED TO BE A SETSCREW PROBLEM. A REVISION PROCEDURE WAS PERFORMED AND THE ASSOCIATED COMPETITIVE ATRIAL LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7646655 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPERIENCING SYNCOPE AND HAD PRESENTED TO AN EMERGENCY DEPARTMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope

  MAUDE report 7408957 ↗

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-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-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-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-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.