EASYTRAK® 2 4518Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 00802526417672), received between Jan 23, 2013 and Sep 24, 2026 — classified as 1 death, 147 injuries, 32 malfunctions.

The most frequently reported specific device problem is “High impedance” (52 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 180 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was surgically abandoned and replaced. No additional adverse patient effects were reported.

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

  MAUDE report 50884363 ↗
• MalfunctionJul 3, 2026Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING RISING PACING IMPEDANCES THAT REMAINED WITHIN NORMAL LIMITS AND HIGHER CAPTURE THRESHOLDS. TECHNICAL SERVICES (TS) ALSO NOTED POSSIBLE LOSS OF CAPTURE (LOC). TS DISCUSSED POSSIBLE PREMATURE VENTRICULAR CONTRACTION (PVC) AND INTERMITTENT MORPHOLOGY THAT FELL OUTSIDE BLANKING. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700639 ↗
• InjuryMay 5, 2026High Capture Threshold

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

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25076277 ↗
• InjuryMar 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 24710764 ↗
• InjuryMar 4, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF DUE TO UNKNOWN REASON. THIS LV REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507292 ↗
• MalfunctionFeb 26, 2026Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE ON THE PRESENTING ELECTROGRAM. THE CLINICIAN PROVIDED THE PATIENT WOULD BE SEEN FOR FURTHER EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454965 ↗
• MalfunctionFeb 12, 2026Failure to Capture; High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD RECORDED HIGH OUT OF RANGE HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS, LOSS OF CAPTURE (LOC), AND LOW INTRINSIC AMPLITUDE. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND RECOMMENDED FURTHER EVALUATION FOR A POTENTIAL LV LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324964 ↗
• InjuryNov 4, 2025Failure to Capture; Fracture; High impedance; Difficult to Remove; Impedance Problem; Material Integrity Problem; Failure to Capture; Fracture; High impedance; Difficult to Remove; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO LEAD FRACTURE RESULTING IN OUT-OF-RANGE IMPEDANCE AND NO CAPTURE. NO NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464632 ↗
• InjuryOct 15, 2025Defective Device; High Capture Threshold; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT DURING A PROCEDURE, THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW LEAD DUE TO A PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280910 ↗
• InjuryAug 29, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926857 ↗
• InjuryJul 22, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS OF 6 VOLTS AT 2 MILLI SECONDS. AS OF THIS TIME, THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ACCORDING TO THE ADDITIONAL INFORMATION, THIS LV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566173 ↗
• InjuryMay 27, 2025Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE AND SUSPECTED LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD CHANNEL. THE HEALTH CARE PROFESSIONAL PERFORMED AN IN-OFFICE EVALUATION AND NOTED CHANGES IN MORPHOLOGY DURING ISOMETRICS AS WELL AS PHRENIC NERVE STIMULATION IN CERTAIN PACING VECTORS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN OPTED TO TURN THE LEFT VENTRICULAR (LV) LEAD PACING OFF AND ALLOW INTRINSIC ACTIVITY TO OCCUR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22093129 ↗
• InjuryMar 17, 2025Fracture; High impedance; Device Sensing Problem; Fracture; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND POOR SENSING. A LV LEAD FRACTURE WAS FOUND. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, AND THE LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621163 ↗
• InjuryDec 2, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20820240 ↗
• InjuryNov 26, 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 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 20777463 ↗
• InjuryNov 7, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. THIS LEAD WAS NOT REPLACED BECAUSE THE PATIENT RECEIVED NEW NON-BOSTON SCIENTIFIC LEADLESS PACEMAKER. THIS LV LEAD WAS RETURNED TO BOSTON SCIENTIFIC BUT FURTHER ANALYSIS HAS NOT BEEN PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS LV LEAD WAS EXPLANTED DUE TO INFECTION. THIS LV LEAD WAS RETURNED TO BOSTON SCIENTIFIC BUT FURTHER ANALYSIS HAS NOT BEEN PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20635020 ↗
• InjuryOct 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED INFECTION AND EROSION. A LASER EXTRACTION WAS PERFORMED WITH THIS LV LEAD. FURTHERMORE, THE PHYSICIAN STATED THAT THE LEADS EXTRACTED WERE TERRIBLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD WILL NOT BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 20349379 ↗
• MalfunctionAug 30, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED A REVIEW OF THE PRESENTING ELECTROGRAM (EGM) OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM DUE TO CONCERNS OF LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD. UPON REVIEW, THE PRESENTING EGM SHOWED THAT THE LV APPEARED TO BE INTERMITTENTLY EXHIBIT LOC. TS RECOMMENDED FOR THE HCP TO SCHEDULE THE PATIENT FOR AN IN-OFFICE VISIT TO FURTHER EVALUATE THE LEAD. AT THIS TIME, THE LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113102 ↗
• InjuryAug 21, 2024Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT RESULTING IN LOSS OF CAPTURE. DISLODGMENT WAS CONFIRMED VIA FLUOROSCOPY. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019382 ↗
• InjuryJul 23, 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 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 19805977 ↗
• InjuryJun 4, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO LEAD WAS DAMAGED DURING THE EXPLANT OF THE RIGHT VENTRICULAR (RV) LEAD. A NEW LEAD WAS IMPLANTED. THIS LEAD WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461785 ↗
• InjuryMay 20, 2024Failure to Capture; Pacing Problem; Impedance Problem; Failure to Capture; Pacing Problem; Impedance Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC), PACING INHIBITION, AND IMPEDANCE ISSUES. THIS RESULTED IN THE EJECTION FRACTION OF THIS PATIENT TO DECREASE FROM 50 TO 35%. A REVISION PROCEDURE WAS PERFORMED, AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19355465 ↗
• MalfunctionMay 20, 2024High impedance; Failure to Read Input Signal; High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED HIGH IMPEDANCE MEASUREMENTS ON THIS LEFT VENTRICULAR (LV) CHANNEL. UPON REVIEW, TECHNICAL SERVICES (TS) STATED THAT THERE WAS AN ABRUPT RISE IN THE IMPEDANCES WITH MEASUREMENTS AT 1425 OHMS. THERE WAS ALSO DECREASE IN INTRINSIC AMPLITUDE WHICH WERE NOTED HIGH EARLIER. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352102 ↗
• InjuryApr 25, 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 A SYSTEM REVISION DUE TO WOUND DEHISCENCE WITH INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 19182334 ↗
• InjuryApr 4, 2024Defective Device; Defective Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039975 ↗

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-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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, 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-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-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-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-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-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.