ACUITY™ X4 Spiral L 4677Recalls & reported problems

Summary

The FDA's MAUDE database contains 729 adverse event reports that list this exact device (DI 00802526524592), received between Apr 19, 2017 and Sep 30, 2026 — classified as 2 deaths, 455 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (130 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 729 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range impedance measurements for its left ventricular (LV) lead. Additionally it exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted discussed the limits for the impedance measurements as well as alert options for out of range impedance measurements. The calling clinician stated that the RV lead was changed to single coil configuration so it was back within established limits. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947728 ↗
• InjurySep 28, 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 50910881 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50784374 ↗
• MalfunctionSep 15, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774138 ↗
• MalfunctionSep 4, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610446 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was explanted due to an unknown product anomaly. A new lead was successfully implanted. No additional adverse patient effects were reported. This LV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602289 ↗
• MalfunctionSep 4, 2026Failure to Capture; Positioning Problem

  It was reported that this patient was scheduled for a cardiac resynchronization therapy defibrillator (CRT-D) upgrade procedure with conduction system pacing (CSP) lead placement. There was difficulty positioning this CSP lead, and there was no capture in the one available branch. Subsequently this LV lead was removed, and the procedure was completed with connecting the chronic right ventricular (RV) defibrillation lead to a new implantable cardioverter defibrillator (ICD) instead. No adverse patient effects were reported. This lead will not be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600921 ↗
• MalfunctionAug 20, 2026Failure to Capture; High Capture Threshold

  It was reported that the cardiac resynchronization therapy defibrillator (CRT-D) and this left ventricular (LV) lead exhibited a loss of capture. There was a high capture threshold on this LV lead. Technical Services (TS) recommended in clinic threshold testing. This LV lead remains in service. No adverse patient effects were reported.Additional information was received. It was reported that the health care professional (HCP) planned to do an LV lead revision. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360096 ↗
• 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 50343448 ↗
• MalfunctionAug 10, 2026High impedance

  It was reported that this cardiac resynchronization therapy pacemaker (CRT-P) exhibited high out of range pacing impedance measurements for its left ventricular (LV) lead, which resulted in its lead safety switch (LSS) to be activated. Technical Services (TS) was consulted and discussed stored data, with the latest data indicating the pacing impedance measurements back in range and all other measurements were within range. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197008 ↗
• MalfunctionAug 10, 2026Difficult to Insert; Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was attempted due to unknown product performance reason. This LV lead was replaced and not implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189527 ↗
• InjuryJul 22, 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 25901839 ↗
• InjuryJul 21, 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 25889448 ↗
• MalfunctionJul 7, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM TRIGGERED LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE LEFT VENTRICULAR (LV) LEAD PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25738409 ↗
• MalfunctionJul 7, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE OUT OF RANGE ABOVE 2500 OHMS, ALONG WITH AN INCREASE IN HIGH CAPTURE THRESHOLDS. TECHNICAL SERVICES (TS) WAS CONSULTED, AND FURTHER IN OFFICE EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25728896 ↗
• InjuryJul 1, 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 25678053 ↗
• InjuryJun 29, 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 25659511 ↗
• InjuryJun 23, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN REASONS AT THIS TIME. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602762 ↗
• InjuryJun 16, 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 25524901 ↗
• InjuryJun 15, 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 25498605 ↗
• InjuryJun 9, 2026Failure to Capture; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM INCLUDING THIS RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED TO LV PACING ONLY, FOLLOWING A PRIOR VENTRICULAR FIBRILLATION (VF) STORM AND HOSPITALIZATION ON LIFE SUPPORT, WITH SUBSEQUENT OBSERVATIONS OF ATRIAL ACTIVITY TRACKING AND RV PACING ASSOCIATED WITH DECREASED BLOOD PRESSURE. PROGRAMMING ADJUSTMENTS WERE PERFORMED TO PREVENT FUSION, AND IT WAS NOTED THAT LV PACING MORPHOLOGY APPEARED NARROWER COMPARED TO RV PACING. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DATA AND NOTED THAT FUSION PATTERNS WERE LIKELY RELATED TO LV PACING GIVEN THE CURRENT PROGRAMMING SETTINGS AND THAT THE LEFT VENTRICULAR PROTECTION PERIOD (LVPP) FEATURE INHIBIT LV PACING AND RESULT IN RV PACING DELIVERY. FURTHER EVALUATION INCLUDED TEMPORARY ATRIAL PACING, DURING WHICH NO FARFIELD OVERSENSING WAS OBSERVED ON THE LV CHANNEL. REVIEW OF THE PRESENTING ELECTROGRAM (EGM) INDICATED THAT R-WAVE DEFLECTIONS ON RV AND LV CHANNELS APPEARED ALIGNED RATHER THAN LV FIRST. TS PROVIDED REPROGRAMMING RECOMMENDATIONS, AND THE FIELD REPRESENTATIVE CONFIRMED LEAD

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Tachycardia; Ventricular Fibrillation

  MAUDE report 25444828 ↗
• InjuryJun 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 25394965 ↗
• InjuryMay 24, 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 25267318 ↗
• MalfunctionMay 22, 2026Failure to Capture; Failure to Read Input Signal

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A LOSS OF CAPTURE ON THIS LEFT VENTRICULAR (LV) LEAD. THE PATIENT WAS SEEN IN OFFICE ON (B)(6) 2026, AND THE THRESHOLD WAS IN RANGE AT THAT TIME. TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND OBSERVED VARYING MORPHOLOGIES. TS SUSPECTED THERE MAY BE A POSITIONAL COMPONENT EFFECTING THRESHOLD VALUE. TS RECOMMENDED FURTHER EVALUATION IN CLINIC. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256635 ↗
• MalfunctionMay 15, 2026Failure to Capture; Failure to Read Input Signal; High Capture Threshold

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THE PRESENTING ELECTROGRAM (EGM) DUE TO SUSPECTED LEFT VENTRICULAR (LV) LEAD LOSS OF CAPTURE (LOC). UPON REVIEW, THE EGM SHOWED AN LEFT VENTRICULAR AUTOMATIC THRESHOLD (LVAT) ALERT THAT INDICATED LVAT WAS DETECTED AS GREATER THAN PROGRAMMED AMPLITUDE OR SUSPENDED DUE TO INTRINSIC BEATS. TS REVIEWED PROVIDED EGM WHICH APPEARED TO SHOW POSSIBLE LV LOC AT HIGHER OUTPUTS HOWEVER TS IS UNABLE TO CONFIRM THE CAPTURE. TS RECOMMENDED THE PATIENT BE BROUGHT IN FOR FURTHER LEAD EVALUATION AND TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182058 ↗

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-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-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-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-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-0825-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100

…and 4 more.