EASYTRAK® 3 IS-1 4548Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00802526420276), received between Oct 3, 2014 and Sep 23, 2026 — classified as 45 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (11 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 54 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50873323 ↗
• InjuryJun 9, 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 EROSION AND INFECTION. THE PATIENT EXPERIENCED EDEMA, INFLAMMATION AND SWELLING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS CUT FROM THE TERMINAL PIN, AND THE LEAD BODY REMAINS IMPLANTED AND INACTIVE.

  Patient problems: Erosion; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25446893 ↗
• MalfunctionApr 15, 2026Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE ON THE PRESENTING ELECTROGRAM. THE HEALTH CARE PROFESSIONAL PROVIDED THE PATIENT WOULD BE SEEN IN CLINIC. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887427 ↗
• InjuryDec 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS AT 5.0 VOLTS AT 2.0 MILLI SECONDS. IN ADDITION, THE PATIENT WITH THIS LV WAS OCCLUDED ON THE LEFT SIDE. CONSEQUENTLY, THIS LV WAS SURGICALLY ABANDONED ALONG WITH DEVICE AND REPLACED WITH NON-BOSTON SCIENTIFIC MODELS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23779324 ↗
• InjuryOct 24, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 23386399 ↗
• InjuryJul 3, 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 REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 22401105 ↗
• InjuryJul 11, 2024Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR LEAD WAS COMPROMISED DURING GENERATOR CHANGE. LEAD EXHIBITED FAILURE TO CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE WITH NO ROOT CAUSE DETERMINED. AS A RESULT, LV LEAD WAS SURGICALLY ABANDONED, AND NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19717185 ↗
• MalfunctionJun 27, 2024Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING OF NOISY SIGNALS AND REACHED LOW OUT OF RANGE IMPEDANCE ONCE. THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REPROGRAM THE LV SENSING OFF. TECHNICAL SERVICES (TS) PROVIDED THEIR INSIGHT ON THE REPROGRAMMING AND POTENTIAL FOLLOWING ACTIONS. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627393 ↗
• InjuryJun 21, 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. THIS LV LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 19582308 ↗
• InjuryMay 1, 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 19224875 ↗
• MalfunctionMay 1, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A LEFT VENTRICULAR (LV) LEAD WAS BEING REPLACED. THE PATIENT IS LV AND RIGHT VENTRICULAR LEAD PACING DEPENDENT. THE LV LEAD HAD BEEN SHOWING HIGH PACING THRESHOLDS. WHEN THE CRT-D WAS TAKEN OUT OF THE POCKET AND THE RV LEAD WAS DISCONNECTED, THE LV LEAD SHOWED LOSS OF CAPTURE (LOC). THE CRT-D WAS REPLACED FOR A NEW ONE AND THE LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219446 ↗
• InjuryOct 24, 2023Adverse 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. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17995445 ↗
• MalfunctionAug 17, 2023Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED NOISY SIGNALS. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND NOTED THAT THE NOISY SIGNALS WERE BEING OVERSENSED AND CAUSED PACING INHIBITION. THE NOISE WAS REPRODUCED WITH ISOMETRICS AND POCKET MANIPULATION. ADDITIONALLY, THERE HAD BEEN HIGH OUT OF RANGE PACING IMPEDANCE IN THE PAST. TS NOTED THAT THERE MAY BE POTENTIAL LOSS OF CAPTURE (LOC). THE HEALTH CARE PROFESSIONAL (HCP) NOTED THAT THERE WAS A PROCEDURE SOME DAYS PRIOR TO THE EVENT, WHICH MAY HAVE AFFECTED THE DEVICE SYSTEM. IT WAS NOTED THAT THE ISSUE WILL LIKELY BE ADDRESSED AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGEOUT AS THE DEVICE DOES NOT HAVE MUCH BATTERY LONGEVITY LEFT. TS PROVIDED PROGRAMMING OPTIONS AND RESOLUTION OPTIONS. THE DEVICE WAS REPROGRAMMED. THE LEAD REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 17563948 ↗
• MalfunctionAug 10, 2023Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High 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. IT WAS NOTED THAT THESE MEASUREMENTS WERE ON THE LV RING PROGRAMMED VECTOR. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND FOUND THAT THERE WAS LV LOSS OF CAPTURE (LOC). THE LV THRESHOLD HAD RISEN FROM 2.6V TO 3.5V. TS DISCUSSED TROUBLESHOOTING INCLUDING ISOMETRIC TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497952 ↗
• InjuryApr 24, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED CHRONIC DIAPHRAGMATIC STIMULATION AND RESULTING PACING OUTPUT NEEDING TO BE REPROGRAMMED AT OR BELOW THRESHOLD FOR ADEQUATE CARDIAC RESYNCHRONIZATION THERAPY (CRT) DELIVERY. THE PATIENT WAS ALREADY SCHEDULED FOR EXTRACTION AND RE-IMPLANT. ADDITIONAL INFORMATION INDICATED THAT THE LEAD WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 16794105 ↗
• InjuryApr 17, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING THRESHOLD MEASUREMENTS. DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE THIS LV WAS CONNECTED TO THE NEW REPLACEMENT DEVICE, BUT SIGNIFICANT MUSCLE STIMULATION WAS OBSERVED. ATTEMPTS TO PROGRAM AROUND THE MUSCLE STIMULATION WERE UNSUCCESSFUL. THE LV LEAD WAS SURGICALLY CAPPED/ABANDONED (I.E., IT REMAINS IMPLANTED, BUT IS NO LONGER IN SERVICE).

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 16751878 ↗
• InjuryApr 7, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD. THE LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704118 ↗
• InjuryMar 14, 2023Adverse 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 16536344 ↗
• InjurySep 7, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH PACING THRESHOLDS. AS A RESULT, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370375 ↗
• InjuryJun 2, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. ALL LEADS HAD THRESHOLDS AND THEREFORE SYSTEM WAS NO LONGER ABLE TO FUNCTION EFFICIENTLY FOR THE PATIENT. ENTIRE SYSTEM WAS EXPLANTED AND REPLACED WITH NEW LEADS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. LEADS WERE SHREDDED DURING EXTRACTION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14582761 ↗
• InjuryApr 27, 2022Adverse 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 POCKET EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14229473 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED LEFT VENTRICULAR (LV) LEAD EXHIBITED INFECTION WITH SEPSIS AND WAS PART OF THE SYSTEM REVISION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14229386 ↗
• InjuryApr 22, 2022Adverse 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 CAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 14189996 ↗
• InjuryApr 9, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY CAPPED/ABANDONED (THE LEAD REMAINS IMPLANTED BUT OUT-OF-SERVICE) DUE TO INCREASING THRESHOLDS. ANOTHER LV LEAD WAS SUCCESSFULLY IMPLANTED. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068096 ↗
• InjuryJan 14, 2022Adverse 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 EXPLANTED DUE TO ENDOCARDITIS. THIS EXPLANTED LV LEAD, ALONG WITH EXPLANTED CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER, RIGHT ATRIAL LEAD, AND RIGHT VENTRICULAR LEAD ARE EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 13262253 ↗

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-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-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-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-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-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.