EASYTRAK® 3 4524Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00802526353758), received between Jun 28, 2018 and Dec 30, 2025 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PREVIOUSLY CAPPED IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23931624 ↗
• MalfunctionOct 28, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547200 ↗
• InjuryMay 2, 2024Adverse 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 WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PREVIOUSLY CAPPED LV LEAD REMAINS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 19235553 ↗
• MalfunctionOct 3, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THERE WERE DIFFICULTIES GETTING THIS LEFT VENTRICULAR (LV) LEAD INTO THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) PROVIDED A RESOLUTION OPTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS LEAD ABLE TO BE CONNECTED TO THE HEADER OF THE DEVICE AFTER PUSHING THE LEAD IN HARDER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859780 ↗
• InjuryOct 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD EXHIBITED INFECTION. REPORTEDLY, WHILE PERFORMING RIGHT VENTRICULAR (RV) LEAD EXTRACTION, THE LEFT VENTRICULAR (LV) LEAD WAS FRACTURED AND THE COIL UNRAVELED; HENCE, THE LV LEAD WAS ABANDONED FOR THE TIME BEING. MOREOVER, WHILE PULLING OUT THE RIGHT ATRIAL (RA) LEAD, THE ANESTHESIOLOGIST NOTICED AN EFFUSION IN THE RIGHT ATRIUM AND THE PATIENT EXPERIENCED CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. SUBSEQUENTLY, AN OPEN-HEART PROCEDURE WAS DONE TO FIX THE EFFUSION. A REVISION WAS PERFORMED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WILL NOT BE RETURNED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion; Unspecified Infection

  MAUDE report 15671040 ↗
• InjuryNov 3, 2021Adverse 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 ERODED AFTER THE PATIENT BUMPED THE DEVICE WHICH DEVELOPED A HEMATOMA THEREFORE THE WHOLE SYSTEM HAD INFECTION WITH SEPSIS. A REVISION WAS PERFORMED AND THE LV LEAD WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Hematoma; Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 12741955 ↗
• InjuryOct 7, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR LEAD WAS EXHIBITING NO CAPTURE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED DURING AN ELECTIVE DEVICE REPLACEMENT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10642707 ↗
• InjuryJul 22, 2020Adverse 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: No Code Available; Unspecified Infection

  MAUDE report 10311553 ↗
• InjuryJul 1, 2020Adverse 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PREVIOUSLY CAPPED LEAD WAS NOW EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 10221620 ↗
• InjuryJan 14, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT ELEVATED THRESHOLD MEASUREMENTS WERE NOTED WITH THIS LEFT VENTRICULAR (LV) LEAD. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THIS LEAD; HOWEVER, SUCCESSFUL PLACEMENT OF A REPLACEMENT LEAD WAS UNSUCCESSFUL. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9588121 ↗
• InjuryJan 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9550824 ↗
• InjuryJan 3, 2020Defective Device; Impedance Problem; Material Integrity Problem; Defective Device; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO IMPEDANCE ISSUES THAT APPEAR TO BE CAUSED BY A LEAD FRACTURE. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9548942 ↗
• MalfunctionMay 6, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT PACING LEAD IMPEDANCE MEASUREMENTS ON THIS LEFT VENTRICULAR (LV) LEAD, WHICH WERE 500 OHMS AT IMPLANT AND WERE CURRENTLY APPROXIMATELY 300 OHMS, HAD DROPPED BELOW 200 OHMS ONE TIME. THIS MEASUREMENT WAS NOT REPRODUCIBLE. THRESHOLDS AND SENSING MEASUREMENTS WERE WITHIN NORMAL LIMITS AND NO NOISE WAS PRESENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584567 ↗
• InjuryMay 6, 2019Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THIS LV LEAD WAS ABANDONED SURGICALLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583987 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8524148 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD AN INFECTION AND EROSION OF THEIR DEVICE SYSTEM. THIS WAS A LIFE-THREATENING SITUATION AND THE PATIENT WAS TREATED. THIS LEAD IS CURRENTLY STILL IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8283297 ↗
• InjuryOct 24, 2018High Capture Threshold; High Capture Threshold

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLDS. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE FOR HIGH THRESHOLD WAS UNCONFIRMED AS LEAD INSULATION LOOKED NORMAL AND X-RAY DID NOT SHOW ANY ABNORMALITIES. THIS LV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000188 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD AN INFECTION AND A SYSTEM EXTRACTION WAS PLANNED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 7648377 ↗

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-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-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-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-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-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.