ACUITY™ X4 Spiral S 4674Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,975 adverse event reports that list this exact device (DI 00802526524554), received between Apr 12, 2017 and Sep 30, 2026 — classified as 16 deaths, 1,317 injuries, 642 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (245 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,975 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away on September 9th, 2026. During a routine cardiac resynchronization therapy defibrillator (CRT-D) system implant, the patient experienced cardiac arrest. The cardiac arrest occurred while this left ventricular (LV) lead was being implanted and after the right ventricular (RV) lead was implanted. Backup pacing was provided on the RV lead. Cardiopulmonary resuscitation (CPR) was given to the patient, and the patient experienced ventricular tachycardia (VT) and ventricular fibrillation (VF) several times. The field representative noted the patient was stable after the procedure. It was later reported by the field representative that the patient passed away overnight. It was noted the CRT-D was never implanted in the patient. This LV lead was an attempted implant. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation

  MAUDE report 50950617 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941339 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50941282 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923949 ↗
• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907234 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to a fall and landed on device which resulted to a pocket infection. After discussion, the physician opted to wash out the pocket. There were no additional adverse patient effects reported. This LV lead remained in service.

  Patient problems: Unspecified Infection

  MAUDE report 50903015 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) system exhibited infection. Subsequently, the device and leads were explanted. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50889337 ↗
• InjurySep 23, 2026Material Integrity Problem

  It was reported that this left ventricular (LV) lead was not successfully implanted due to the pigtail portion not straightening as intended when a Whisper wire was advanced through the distal tip, resulting in perforation of the lead insulation and exit through the insulation. This LV lead was not implanted, was replaced with a new LV lead of the same model and returned for analysis. No adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50871438 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was explanted due to the patient suffering an infection. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50818134 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50777466 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50774390 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744419 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50739872 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50725377 ↗
• MalfunctionSep 10, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50724868 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50711054 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was part of a system revision due to infection. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50611794 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50606761 ↗
• InjurySep 4, 2026High Capture Threshold

  It was reported that this left ventricular (LV) lead was explanted and replaced due to high thresholds. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602118 ↗
• MalfunctionSep 4, 2026Failure to Capture; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high capture thresholds and loss of capture (LOC) for its left ventricular (LV) lead. Technical Services (TS) was consulted and discussed programming options and settings. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601423 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50594221 ↗
• InjurySep 3, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was a part of t an entire system was extraction due to non-compliant patient and lead dislodgement. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594218 ↗
• InjurySep 2, 2026No Apparent Adverse Event

  Patient problems: Unspecified Infection

  MAUDE report 50566125 ↗
• MalfunctionAug 28, 2026Adverse Event Without Identified Device or Use Problem; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509676 ↗
• InjuryAug 20, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead and the right ventricular (RV) lead were explanted due to an unknown product performance issue. This LV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351155 ↗

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-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-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-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-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-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-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-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-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.