ACUITY™ X4 Spiral L 4678Recalls & reported problems

Summary

The FDA's MAUDE database contains 171 adverse event reports that list this exact device (DI 00802526524615), received between Jan 17, 2018 and Aug 21, 2026 — classified as 2 deaths, 98 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Defective Device” (29 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 171 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2026Insufficient Device Problem Information

  It was reported that this left ventricular (LV) lead was attempted due to an unknown circumstances. The replacement procedure was successfully performed with another Non-Boston Scientific lead that was successfully implanted instead. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380868 ↗
• MalfunctionAug 19, 2026Pacing Problem

  Patient problems: Asystole; Bradycardia

  MAUDE report 50329752 ↗
• InjuryAug 17, 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 50274602 ↗
• InjuryJul 30, 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 50079098 ↗
• MalfunctionJul 1, 2026Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SUSPECTED TO HAVE EXHIBITED LOSS OF CAPTURE. TECHNICAL SERVICES (TS) WAS CONSULTED TO REVIEW THE PRESENTING ELECTROGRAM, IN WHICH TS AGREED A DEFLECTION ON THE LV WAS LATE, MAKING IT DIFFICULT TO CONFIRM LOSS OF CAPTURE. TS NOTED THE SYSTEM WAS RECENTLY IMPLANTED AND HAD FEW DAILY MEASUREMENTS; HOWEVER, MEASUREMENTS FROM A LEFT VENTRICULAR AUTOMATIC THRESHOLD TEST ALSO EXHIBITED POSSIBLE LOSS OF CAPTURE. TS RECOMMENDED TO EVALUATE THE LEAD IN CLINIC AND SUGGESTED X RAYS OF THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680076 ↗
• 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: Bacterial Infection; Unspecified Infection

  MAUDE report 25676328 ↗
• MalfunctionJun 10, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS BRADY LEAD WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO NO ACCEPTABLE THRESHOLD MEASUREMENTS AND IN ONE LOCATION DIAPHRAGMATIC STIMULATION WAS UNAVOIDABLE. THIS BRADY LEAD WAS REPLACED WITH DIFFERENT MODEL, NOT IMPLANTED AND WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25458157 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO CONCERNS OF INFECTION AS THE DEVICE ERODED. A NEW LEAD IS EXPECTED TO BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD IS NO LONGER IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 25257450 ↗
• MalfunctionMay 15, 2026Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD JUST A DAY AFTER IMPLANT. TECHNICAL SERVICES (TS) RECOMMENDED FOLLOW UP IN CLINIC TO TEST THE THRESHOLDS AND CONFIRM CAPTURE. THIS CRT-D AND LV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186863 ↗
• MalfunctionApr 20, 2026Failure to Capture; High impedance; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXPERIENCED MUSCLE STIMULATION. LV LEAD WAS REPROGRAMMED TO AVOID STIMULATION. THE REPRESENTATIVE CALLED BACK AND TESTED A FEW PACING OPTIONS AND IT APPEARS TO BE AN RV ISSUE. THE OUTPUTS WERE AT 4.5 V. ADDITIONALLY, IT WAS FOUND OUT THAT THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE WAS AT 700'S OHMS AND THEN ROSE A COUPLE OF WEEKS AGO. ENGINEERING ANALYSIS WAS SUBMITTED. ANALYSIS CONFIRMED THAT THERE WAS A JUMP IN THE LV LEAD IMPEDANCE AND DEVICE POWER CONSUMPTION AND TECHNICAL SERVICES (TS) SUGGESTED TO OPTIONS TO PROGRAM LV BACK TO LV2_TO_LV3 AND SEE IF THE ISSUES RESOLVE OR TO TREAT THIS AS A GATE OXIDE MALFUNCTION AND REPLACE THE PG AND CONSIDER THE POSSIBILITY OF LEAD DAMAGE VIA CORROSION. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924688 ↗
• InjuryApr 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, POCKET EROSION, AND CELLULITIS. ADDITIONALLY, THE CRT-D WAS MIGRATED AND HAD A BRUISE WAS NOTED UNDER THE LEFT BREAST AREA. REPORTEDLY, THE PATIENT ALSO HAD SWOLLEN BREAST AREA AND FLUID RETENTION AROUND THE IMPLANT SITE. FURTHERMORE, THE PATIENT ADVOCATE MENTIONED OF THE POSSIBLE ALLERGIC REACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Bruise/Contusion; Cellulitis; Fluid Discharge; Hypersensitivity/Allergic reaction; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 24892313 ↗
• MalfunctionMar 4, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) IN THE LEFT VENTRICULAR (LV) LEAD. IN ADDITION, HIGH THRESHOLD VALUES WERE NOTED FOR BOTH THE LV AND RIGHT VENTRICULAR (RV) LEADS . TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS. THIS LEFT VENTRICULAR (LV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Dyspnea; No Clinical Signs, Symptoms or Conditions; Unspecified Heart Problem

  MAUDE report 24508300 ↗
• MalfunctionFeb 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT THIS BRADY LEAD WAS NOT SUCCESSFULLY IMPLANTED DUE TO LEAD BREAKAGE OR FRACTURED AS THE HELIX DID NOT EXHIBIT NORMAL BEHAVIOR. ADDITIONALLY, A WIRE PERFORATED THROUGH THE LEAD, AND THIS BRADY LEAD HAD TO BE DISCARDED. THEN A NEW BRADY LEAD OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. THE BRADY LEAD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473443 ↗
• InjuryFeb 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT IMPLANTED SUCCESSFULLY DUE TO HIGH THRESHOLDS AND DIAPHRAGMATIC STIMULATION WHILE PACING. MEDICATION WAS ADMINISTERED. THIS LV LEAD WAS REPLACED WITH A DIFFERENT MODEL AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 24457262 ↗
• InjuryFeb 12, 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 24325117 ↗
• MalfunctionFeb 11, 2026Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS AN ATTEMPTED IMPLANT DUE TO LOSS OF CAPTURE (LOC). A NEW LV LEAD WAS IMPLANTED INSTEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314167 ↗
• InjuryFeb 10, 2026Failure to Capture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. ANOTHER LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THIS LV LEAD EXHIBITED A LOSS OF CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308005 ↗
• MalfunctionJan 27, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD PRESENTED A LEAD SAFETY SWITCH (LSS) DUE TO A HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENT. TECHNICAL SERVICES (TS) REVIEWED THE LEAD TREND AND NOTED STABLE IMPEDANCE VARIABILITY FROM 1500 TO 1900 OHMS SINCE IMPLANT. TS ALSO NOTED THAT THE SPECIFIED IMPEDANCE RANGE FOR THIS LEAD WAS 200 TO 3000 OHMS. TS PROVIDED PROGRAMMING RECOMMENDATIONS AND SUGGESTED INCREASING THE OUT OF RANGE THRESHOLD TO 3000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192856 ↗
• MalfunctionDec 22, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING LOSS OF CAPTURE ON THE LV CHANNEL. THE PATIENT WILL BE EVALUATED IN THE CLINIC. THIS CRT-D SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863273 ↗
• MalfunctionDec 2, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) HAD CONCERNS FOR THE PRESENTING ELECTROGRAM (EGM) THIS LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND DETERMINED THAT THERE APPEARED TO BE OVERSENSING ON THE LV CHANNEL. TS PROVIDED REPROGRAMMING OPTIONS TO AVOID OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694524 ↗
• MalfunctionOct 28, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS BRADY LEAD WAS ATTEMPTED DUE TO UNKNOWN PRODUCT PERFORMANCE REASON. THIS BRADY LEAD WAS REPLACED AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409850 ↗
• MalfunctionOct 3, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD IMPLANT WAS ATTEMPTED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. A DIFFERENT LEAD MODEL WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23207275 ↗
• MalfunctionSep 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT IMPLANTED SUCCESSFULLY DUE TO PRODUCT PERFORMANCE ISSUE. A NEW LV LEAD WITH A DIFFERENT MODEL WAS PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23177339 ↗
• MalfunctionSep 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT WHILE PREPARING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM FOR A MAGNETIC RESONANCE IMAGING (MRI) SCAN, HIGH OUT-OF-RANGE LEFT VENTRICULAR (LV) LEAD PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE OBSERVED. A VECTOR BREAKDOWN SHOWED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS FOR MOST VECTORS INCLUDING LV1. THE LV LEAD WAS REPROGRAMMED TO LV2-LV3 WHERE STABLE, IN-RANGE IMPEDANCES WERE OBSERVED IN THE 1,265-1,295 OHMS RANGE. THE FIELD REPRESENTATIVE PLANNED TO CONSULT WITH THE HEALTH CARE PROFESSIONAL (HCP) FOR FURTHER GUIDANCE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MRI WAS COMPLETED WITHOUT ISSUES. THIS LV LEAD REMAINS IN SERVICE AND WILL CONTINUE TO BE MONITORED VIA NORMAL FOLLOW-UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158694 ↗
• MalfunctionSep 19, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. THIS LV LEAD WAS REPLACED WITH SAME MODEL AND NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100502 ↗

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-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-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-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-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-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-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-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.