ACUITY™ X4 Straight 4672Recalls & reported problems

Summary

The FDA's MAUDE database contains 509 adverse event reports that list this exact device (DI 00802526524530), received between Jul 10, 2017 and Sep 30, 2026 — classified as 4 deaths, 379 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (99 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 509 reports, in the reporter's own words as published by the FDA.

• InjurySep 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 50942570 ↗
• 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 infection. The patient was treated with antibiotics. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50895921 ↗
• MalfunctionSep 10, 2026Failure to Capture; High Capture Threshold

  It was reported that this left ventricular (LV) lead had high thresholds and LV loss of capture (LOC) was observed on the presenting electrogram (EGM). The programmed LV output was increased, and LV revision may be considered at battery replacement time. This LV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50704037 ↗
• MalfunctionSep 4, 2026Positioning Problem; Insufficient Device Problem Information

  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; Pericardial Effusion

  MAUDE report 50601430 ↗
• InjurySep 4, 2026Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was explanted due to it becoming dislodged. A new LV lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601422 ↗
• InjurySep 2, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead was capped and surgically abandoned due to it becoming dislodged. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566308 ↗
• InjuryAug 20, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that this left ventricular (LV) lead exhibited loss of capture (LOC) one day after it was implanted. X-ray imaging was performed and it was confirmed the LV lead had become dislodged. Subsequently it was explanted. A new LV lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360100 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50320611 ↗
• InjuryAug 14, 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 50263476 ↗
• 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. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50202748 ↗
• InjuryAug 3, 2026Insufficient Device Problem Information; High Capture Threshold

  It was reported that this left ventricular (LV) lead was explanted the day after being implanted with the cardiac resynchronization therapy defibrillator (CRT-D) system. No new LV lead was implanted. No additional adverse patient effects were reported.

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

  MAUDE report 50124469 ↗
• InjuryJul 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 and erosion. Reportedly, the patient experienced discomfort, pain, edema, inflammation, swelling and fluid discharge. There were no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Discomfort; Erosion; Fluid Discharge; Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50059231 ↗
• MalfunctionJul 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT IMPLANTED SUCCESSFULLY DUE TO PRODUCT PERFORMANCE ANOMALY AND NO NEW LV LEAD WAS PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762739 ↗
• InjuryJun 30, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD A HIGH CAPTURE THRESHOLD. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO DE-ACTIVATE THE LEAD, WHICH REMAINED IMPLANTED. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673581 ↗
• MalfunctionJun 25, 2026High impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED ABOUT PROGRAMMING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) FOR MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE AND FOUND THE LEFT VENTRICULAR (LV) LEAD PACING IMPEDANCE MEASUREMENTS WERE FOUND TO BE HIGH OUT OF RANGE. THE LEAD WAS CHECKED AND THE IMPEDANCES WERE GRADUALLY RISING. THE DEVICE WAS NOT PROGRAMMED INTO MRI PROTECTION MODE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622828 ↗
• MalfunctionJun 12, 2026High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. IT WAS NOTED THAT THE PATIENT HAD A RECENT THERAPY UPGRADE FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IN (B)(6) 2026, AND THIS LV LEAD WAS IMPLANTED AT THAT TIME. LV LEAD TRENDS SHOWED A RISE IN LV PACE IMPEDANCE MEASUREMENTS FROM 1,400 OHMS IN (B)(6) 2026, TO A MORE RECENT MEASUREMENT OF 1,779 OHMS. LEFT VENTRICULAR AUTOMATIC THRESHOLD (LVAT) TESTS WERE STABLE WITH MEASUREMENTS IN THE 1.2 TO 1.4 V RANGE, AND THERE WAS NO EVIDENCE OF LV NOISE ON THESE TESTS. ADDITIONALLY, LV SENSING WAS OPTIMAL. IT WAS NOTED THAT THE PATIENT WAS SEEN IN-CLINIC ONE WEEK PRIOR TO THE DATE OF REPORT. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS LV LEAD REMAINS IN SERVICE, AND WILL CONTINUE TO BE MONITORED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25486764 ↗
• InjuryJun 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25476582 ↗
• MalfunctionJun 11, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS ON THIS LEFT VENTRICULAR (LV) LEAD GREATER THAN 3000 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25466223 ↗
• InjuryJun 10, 2026Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM UNDERWENT A TRICUSPID VALVE REPLACEMENT. IT WAS UNKNOWN IF THE LEADS CONTRIBUTED TO THE TRICUSPID VALVE NEEDING REPLACEMENT. DURING THE PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD, THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD AND THIS LEFT VENTRICULAR (LV) LEAD WERE CUT AT THE SUPERIOR VENA CAVA (SVC) JUNCTION AND SURGICALLY ABANDONED. A PORTION OF THE LV LEAD REMAINED IN THE CORONARY SINUS. IT WAS NOTED THAT THE CRT-P REMAINED IMPLANTED IN THE PATIENT, AND A LEADLESS PACEMAKER WAS ALSO IMPLANTED. THE CRT-P WAS REPROGRAMMED DUE TO THE LEADS BEING SURGICALLY ABANDONED. AFTER THE PROCEDURE, AN ALERT WAS OBSERVED FOR LOW OUT OF RANGE IMPEDANCE ON THE RA LEAD AND HIGH OUT OF RANGE PACING IMPEDANCE ON THE RV AND LV LEAD. HOWEVER, THESE ALERTS WERE DUE TO THE LEADS BEING SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25460174 ↗
• 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 25452716 ↗
• InjuryMay 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25246647 ↗
• InjuryMay 19, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. ADDITIONALLY, HIGH CAPTURE THRESHOLDS WERE ALSO NOTED. TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE INFORMATION AVAILABLE. THIS LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224965 ↗
• InjuryMay 19, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT CONFIRMED THROUGH X-RAY, RESULTING IN LOSS OF CAPTURE (LOC) AND A NEW LV LEAD OF A DIFFERENT MODEL WAS PLACED. THIS LEAD WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25213107 ↗
• InjuryMay 13, 2026High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED A DIAPHRAGMATIC STIMULATION UPON ROUTINE INTERROGATION. THE AVAILABLE VECTORS WERE REVIEWED AND NOTED THAT THERE WAS NO ACCEPTABLE COMBINATION OF A GOOD PACING THRESHOLD AND LOW DIAPHRAGMATIC STIMULATION THRESHOLD. THIS LV LEAD WAS EXPLANTED, REPLACED WITH DIFFERENT MODEL AND WAS DISPOSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25161384 ↗
• InjuryMay 1, 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 25054796 ↗

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-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-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-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-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-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-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.