ACUITY™ X4 Straight 4671Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,875 adverse event reports that list this exact device (DI 00802526524516), received between Apr 11, 2017 and Sep 28, 2026 — classified as 5 deaths, 1,374 injuries, 496 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (381 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,875 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Capture; Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924759 ↗
• InjurySep 28, 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 were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50918985 ↗
• InjurySep 24, 2026High Capture Threshold

  It was reported that the patient exhibited a high left ventricular (LV) pacing threshold. This will be addressed when the system review takes place. No adverse patient effects were reported.Additional information from the field representative indicates that this left ventricular (LV) lead was explanted. A new lead was successfully implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885203 ↗
• InjurySep 23, 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 50865758 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead exhibited dislodgement following implantation. Subsequently, the lead was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602273 ↗
• InjurySep 4, 2026High Capture Threshold

  It was reported that this left ventricular (LV) lead was capped due to high capture thresholds. A new LV lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602147 ↗
• 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 were no additional adverse patient effects reported. This LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50601346 ↗
• MalfunctionSep 4, 2026Failure to Capture

  It was reported that the health care professional (HCP) called Technical Services (TS) for further review of the presenting electrogram (EGM) due to concerns of loss of capture (LOC) on the left ventricular (LV) lead. Upon review, intermittent loss of capture (LOC) on the LV lead was observed. The HCP stated plans to schedule patient for an in clinic visit for further lead evaluation. No adverse patient effects were reported. This LV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601332 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50599859 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead had exhibited infection due to infected breast implant. As of this time, this LV lead remains in service. There was no additional adverse patient effects reported.

  Patient problems: Unspecified Infection

  MAUDE report 50566536 ↗
• MalfunctionAug 24, 2026Failure to Capture; Low impedance; High Capture Threshold

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

  MAUDE report 50416014 ↗
• InjuryAug 22, 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 50385660 ↗
• InjuryAug 21, 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 50368194 ↗
• InjuryAug 20, 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 50341416 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead exhibited intermittent phrenic nerve stimulation. The patient felt the stimulation during tests and when sitting up in a chair. The patient underwent a medical intervention to surgically abandon the lead and implant a new left bundle branch (LBB) lead. No additional adverse patient effects were reported.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50306526 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50297049 ↗
• InjuryAug 18, 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 50295717 ↗
• MalfunctionAug 18, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293548 ↗
• MalfunctionAug 17, 2026Positioning Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270025 ↗
• InjuryAug 14, 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 50263481 ↗
• InjuryAug 13, 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 50231050 ↗
• MalfunctionAug 11, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216474 ↗
• InjuryAug 11, 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 and pocket erosion. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 50214672 ↗
• InjuryAug 11, 2026Failure to Capture; Over-Sensing

  It was reported that this left ventricular (LV) lead exhibited oversensing of atrial activity. During in-clinic evaluation, atrial oversensing on the left ventricular (LV) lead. LV sensing was turned off. Intermittent LV loss of capture was also observed. This lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213578 ↗
• MalfunctionAug 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201448 ↗

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-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-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-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-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-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-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.