EASYTRAK® 3 IS-1 4549Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00802526420399), received between Apr 22, 2016 and May 21, 2026 — classified as 103 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (36 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 135 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Failure to Capture

  IT WAS REPORTED THAT THERE WAS A CONCERN ABOUT POTENTIAL LOSS OF CAPTURE (LOC) ON THIS LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW OF PRESENTING ELECTROGRAM (EGM), DETERMINED THAT THIS LEAD EXHIBITED INTERMITTENT LOC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243950 ↗
• MalfunctionMar 25, 2026Low impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD RECORDED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND, WHILE THE MOST RECENT IN-OFFICE MEASUREMENT WERE WITHIN NORMAL LIMITS, LOW OUT OF RANGE VALUES WERE NOTED A FEW MONTHS PRIOR. SENSING AND PACING THRESHOLDS REMAINED STABLE. TS ADVISED THAT LOW IMPEDANCE VALUES MAY SUGGEST POTENTIAL INSULATION DEGRADATION AND CONTINUED MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684009 ↗
• MalfunctionJan 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) REGARDING STORED EPISODES ASSOCIATED. THE FACILITY INFORMED THIS LEFT VENTRICULAR (LV) LEAD HAD A KNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945567 ↗
• MalfunctionDec 2, 2025Over-Sensing; Failure to Read Input Signal; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW THE PRESENTING ELECTROGRAM (EGM) ON THIS LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA, NOTED PREMATURE VENTRICULAR CONTRACTION (PVC) FOR SOME TIME AND WONDERED IF THERE IS EVIDENCE OF A POSSIBLE DISLODGMENT OR AN EXPERIENCED FALL. ADDITIONALLY, ALERTS OF LOW INTRINSIC AMPLITUDE OUT OF RANGE AND PACING PERCENTAGES BELOW THE PROGRAMMED THRESHOLDS WERE NOTED. THE PLAN IS TO CONTINUE TO MONITOR AND FURTHER EVALUATE IN AN IN-CLINIC VISIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LV LEAD SHOWED DEFLECTIONS THAT COULD BE POTENTIAL OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696773 ↗
• InjuryNov 27, 2025Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD A DIAPHRAGMATIC STIMULATION BY THE ABDOMEN AND THUMPING IN ON THE CHEST AND REPROGRAMMING WAS MADE AND RESOLVED. HOWEVER, THE SYMPTOMS REOCCURRED. PATIENT WAS SUGGESTED TO HAVE THIS LV LEAD TURNED OFF. AS OF THIS TIME, THIS LV REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT LV LEAD IS STILL ON AND ACTIVE WITH NO STIMULATION AS OF THE PRESENT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23666175 ↗
• MalfunctionNov 18, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE (LOC). THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587375 ↗
• MalfunctionNov 13, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING OF THE ATRIAL EVENTS IN THE LV CHANNEL. THIS CAUSED A DECREASE IN THE LV PACING PERCENTAGE AND PACING INHIBITION. TECHNICAL SERVICES (TS) RECOMMENDED TURNING LV SENSING OFF AND TO BRING IN THE PATIENT TO ENSURE LEAD MEASUREMENTS WERE IN RANGE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THE OVERSENSING WAS CAUSED BY THE LEAD POSITION. THE PATIENT WAS NOT PACER DEPENDENT. LV SENSING WAS TURNED OFF AND IT WAS CONFIRMED LEAD MEASUREMENTS WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546604 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23088629 ↗
• InjuryAug 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS MOST OF THE TIME. TECHNICAL SERVICES (TS) REVIEWED NOTING LV THRESHOLDS ARE STABLE AND THAT THE LV SENSING IS PROGRAMMED OFF. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853850 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD EXTRACTION PROCEDURE, THE OUTER CONDUCTOR OF THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE FRACTURED. IT WAS FUNCTIONING OK IN UNIPOLAR AND WAS SUCCESSFULLY CAPTURING SO IT WAS LEFT AS IS. THIS WAS NOTED TO BE VISIBLE ON X RAY UNDER THE CLAVICLE. THE PROCEDURE CASE WAS 3 AND A HALF HOURS AND THE PHYSICIAN OPTED TO FINISH THE CASE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669215 ↗
• InjuryJul 7, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF SENSING FROM THE TIP TO RING. THE PATIENT WAS REQUESTING THE LV LEAD BE TURNED OFF WITH NO REASON SPECIFIED. TECHNICAL SERVICES (TS) REVIEWED THE CASE AND WAS CONSIDERING PROGRAMMING CHANGES. THIS LEAD WAS ELECTRICALLY ABANDONED BASED ON THE PATIENT REQUEST. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413632 ↗
• MalfunctionJul 6, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD. IN ADDITION, HIGH PACING THRESHOLDS WERE NOTED. THE PATIENT HAD PHRENIC NERVE STIMULATION PRIOR THE EVENT. TECHNICAL SERVICES (TS) SUSPECTED THAT THIS BEHAVIOR COULD BE RELATED TO THE LV LEAD POSITION, BUT IT WAS NOT CONCLUSIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22408631 ↗
• InjuryJul 4, 2025Failure to Capture; Fracture; Failure to Capture; Fracture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO FRACTURED AND NOTED LOSS OF CAPTURE (LOC). A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401872 ↗
• MalfunctionDec 13, 2024Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND AN ABRUPT CHANGE IN PACE IMPEDANCE MEASUREMENTS FROM 773 OHMS TO 2377 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND A CHEST X RAY WAS RECOMMENDED TO EVALUATE THE LV LEAD LOCATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925439 ↗
• InjuryDec 2, 2024Failure to Capture; Fracture; Defective Device; Failure to Capture; Fracture; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828430 ↗
• InjuryNov 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY EXPLANTED DUE TO LEAD BREAKAGE OR FRACTURE. THIS LV LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805831 ↗
• InjuryNov 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE PROBLEM. DURING THIS PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ALSO EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592705 ↗
• InjuryOct 28, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO A PRODUCT PERFORMANCE ISSUE. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545890 ↗
• InjurySep 16, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED AND REPLACED DUE TO NON-CAPTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT X-RAYS CONFIRMED ALL LEADS WERE IN THE SAME POSITION PRIOR TO LEAD EXPLANT. NO PACING SYSTEM ANALYZER (PSA) TESTING WAS NOTED PRIOR TO EXPLANT. ADDITIONALLY, ELEVATED THRESHOLDS WERE OBSERVED AT MULTIPLE CHECKS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233551 ↗
• InjurySep 5, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD UNDERWENT A REPLACEMENT PROCEDURE DUE TO A PRODUCT PERFORMANCE ISSUE. THE LV LEAD WAS NOT CAPTURING CORRECTLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. THIS LV LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147107 ↗
• InjurySep 2, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH THRESHOLD WITH HIGH OUTPUT AT 5.0 VOLTS AND 1.0 MILLI SECONDS. THE SUSPECTED CAUSE WAS DUE TO PATIENT CONDITION. THE VECTORS WERE CHANGED TO ACHIEVE THE LOWER THRESHOLD, AND ALL OTHER VECTORS HAD STIMULATION. THIS LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 20115865 ↗
• InjuryAug 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO FRACTURE. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20090285 ↗
• MalfunctionJul 1, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT AFTER THE PATIENT EXPERIENCE A FALL AND HAD FRACTURE RIBS. THERE WERE CONCERNS OF LOSS OF CAPTURE (LOC) OF THIS LEFT VENTRICULAR (LV) LEAD DUE TO SIGNS OF POTENTIAL INTERMITTENT CAPTURE. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER EVALUATION OF THE LEAD AND A CHEST X-RAY. NO ADVERSE PATIENT EFFECTS. WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651787 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19356182 ↗
• MalfunctionApr 29, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED DUE LEFT VENTRICULAR (LV) LEAD LOSS OF CAPTURE (LOC) CONCERNS BASED ON A PRESENTING EGM FROM (B)(6) 2024. WHEN COMPARED TO A PRIOR PRESENTING EGM FROM (B)(6) 2023, THE MORPHOLOGY WAS DIFFERENT AND THE CONFIGURATION WAS THE SAME. FURTHER EVALUATION WAS RECOMMENDED. THE LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209783 ↗

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-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-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-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-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-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-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.