EASYTRAK® 2 IS-1 4542 (UDI 00802526579806)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00802526579806), received between Apr 25, 2016 and Sep 18, 2025 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 29 reports, in the reporter's own words as published by the FDA.

• 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23090583 ↗
• InjurySep 2, 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 EXPLANTED DUE TO A NON-PRODUCT EXPERIENCE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THIS LEAD WAS EXPLANTED DUE TO A THERAPY UPGRADE. THERE WERE NO ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946008 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO A POCKET EROSION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22938340 ↗
• InjuryApr 17, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS PARTIALLY EXPLANTED, AND PORTION REMAINS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21858660 ↗
• InjuryFeb 11, 2025Failure to Capture; Fracture; High impedance; Device Sensing Problem; Failure to Capture; Fracture; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS PATIENT'S PACEMAKER WAS BEEPING. UPON INTERROGATION IN CLINIC, IT WAS FOUND THAT THE PACEMAKER WAS AT ITS ELECTIVE REPLACEMENT INDICATOR (ERI). AT LAST CHECK APPROXIMATELY THREE MONTHS PRIOR, THE BATTERY LIFE ESTIMATE WAS ONE YEAR LEFT. AN ANALYSIS OF DEVICE DATA TO DETERMINE BATTERY STATUS WAS DECLINED. IT WAS ALSO FOUND THAT THE INTRINSIC AMPLITUDE OF THE LEFT VENTRICULAR (LV) LEAD WAS HIGH AT GREATER THAN 25 MV ALONG WITH INTERMITTENT LOSS OF CAPTURE (LOC) AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS LV LEAD WAS SURGICALLY ABANDONED DURING A SCHEDULED GENERATOR CHANGE OUT PROCEDURE. A NEW LV LEAD WAS SUCCESSFULLY PLACED. IT WAS NOTED THAT THERE WAS A BREAK/FRACTURE IN THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355884 ↗
• InjuryDec 10, 2024Fracture; Defective Device; Fracture; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED INDICATING LV LEAD HAD FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889542 ↗
• InjuryOct 21, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LV THRESHOLD WAS 4.5 VOLTS AT 2 MILLISECONDS. THE PHYSICIAN STATED THAT THE PATIENT WILL BE SCHEDULED FOR DEVICE CHANGE AND LV LEAD REVISION. SUBSEQUENTLY, THIS LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493936 ↗
• InjuryJun 8, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE THROUGH DEVICE TESTING. AN X-RAY WAS PERFORMED AND NO DISLODGEMENT OR FRACTURE WAS CONFIRMED. THE PHYSICIAN FELT THE PATIENT NO LONGER NEEDED A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19493579 ↗
• InjurySep 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 SURGICALLY ABANDONED DUE TO AN UNKNOWN REASON AT THE TIME OF A NON BOSTON SCIENTIFIC PROCEDURE. IT WAS NOTED THERE WAS NO BOSTON SCIENTIFIC FIELD REPRESENTATIVE INVOLVEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745132 ↗
• InjuryJun 29, 2018Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS AND DISLODGEMENT. THE LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650559 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. REPORTEDLY, THE PATIENT ALSO HAD SEPSIS. THE PATIENT WAS ALSO PUT ON INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Erosion; Sepsis; Unspecified Infection

  MAUDE report 7358565 ↗
• InjuryJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. REPORTEDLY, THE PATIENT¿S CHEMOTHERAPY PORT WAS INFECTED DUE TO BACTEREMIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV WAS EXPLANTED.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 7200350 ↗
• InjuryJan 17, 2018Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. ADDITIONAL INFORMATION INDICATED THAT THE LEAD EXHIBITED LOSS OF CAPTURE. AN X-RAY AND FLUOROSCOPY WAS PERFORMED WHICH CONFIRMED LEAD DISLODGEMENT. THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199369 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND SEPSIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THIS LV LEAD WAS EXPLANTED AND A NEW SYSTEM WAS IMPLANTED ON THE LEFT SIDE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7190487 ↗
• InjuryOct 10, 2017Failure to Capture; Fracture; High impedance; Pacing Problem; Failure to Capture; Fracture; High impedance; Pacing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM EXHIBITED NO PACING OUTPUT, NO CAPTURE AND PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS ON THE LEFT VENTRICULAR (LV) CHANNEL THROUGH THE DEVICE AND A PACING SYSTEM ANALYZER (PSA). A LEAD FRACTURE WAS SUSPECTED BUT WAS NOT VISUALLY CONFIRMED. A REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6933869 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO POCKET EROSION. IT WAS NOTED THAT THIS PATIENT HAD A HISTORY OF ENDOCARDITIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Pocket Erosion

  MAUDE report 6702668 ↗
• InjuryApr 11, 2017Pacing Problem; Extracardiac stimulation; Device Dislodged or Dislocated; Pacing Problem; Extracardiac stimulation; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING INHIBITION AND WAS FOUND TO BE DISLODGED ONE DAY POST IMPLANT. THE PATIENT EXPERIENCED STIMULATION, HOWEVER, DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE PACING INHIBITION. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Muscle Stimulation

  MAUDE report 6480398 ↗
• InjuryApr 10, 2017Failure to Capture; Device Dislodged or Dislocated; Impedance Problem; Failure to Capture; Device Dislodged or Dislocated; Impedance Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ROUTINE FOLLOW-UP, THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED IMPEDANCE MEASUREMENT ANOMALIES AS WELL AS LOSS OF CAPTURE. IT WAS DETERMINED THE LEAD HAD DISLODGED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6475803 ↗
• InjuryApr 10, 2017Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO HYPERTENSION, DIZZINESS AND WORSENING HEART FAILURE. UPON DEVICE REVIEW, IT WAS FOUND THE PATIENT WENT INTO ATRIAL FIBRILLATION. THE DEVICE ALSO WAS FOUND TO HAVE EXHIBITED UNDERSENSING AND OVERSENSING WAS OBSERVED ON THE LEFT VENTRICULAR (LV) CHANNEL. THE LV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Dizziness; High Blood Pressure/ Hypertension; Non specific EKG/ECG Changes

  MAUDE report 6475313 ↗
• InjuryOct 13, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED. ADDITIONAL INFORMATION INDICATES THAT THE LV LEAD DISLODGEMENT WAS CONFIRMED VIA X-RAY. THE LV LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6026938 ↗
• InjuryAug 2, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED TWO MONTHS POST IMPLANT FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5840173 ↗
• InjuryJul 27, 2016Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS. ADDITIONALLY, DURING A ROUTINE CHECK, IT WAS DETERMINED THAT THIS LEAD PULLED BACK DUE TO TWIDDLERS AND/OR DUE TO PATIENT'S BODY HABITUS. THE LEAD'S LUMEN WAS CLOTTED SO THE PHYSICIAN OPTED TO REPLACE THE LEAD. THIS LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 5826314 ↗
• InjuryJul 25, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS DISLODGED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5819186 ↗
• InjuryJul 16, 2016Failure to Capture; Device Dislodged or Dislocated; Impedance Problem; Failure to Capture; Device Dislodged or Dislocated; Impedance Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. ADDITIONAL INFORMATION INDICATES THAT THE DISLODGEMENT WAS CONFIRMED VIA X-RAY. LOSS OF CAPTURE AND CHANGE IN IMPEDANCE WERE NOTED. THIS LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5801233 ↗
• InjuryJul 13, 2016Fracture; High impedance; Capturing Problem; Device Sensing Problem; Fracture; High impedance; Capturing Problem; Device Sensing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW SENSED AMPLITUDES, HIGH PACING THRESHOLDS, HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS, AND WAS SUSPECTED OF A FRACTURE. THE PATIENT REPORTED THAT HE HAD FELT "SOMETHING POP" SHORTLY AFTER IMPLANT OF THIS LEAD WHEN HE HAD CAUGHT A HEAVY ITEM. SUBSEQUENTLY, THIS LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5789116 ↗

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-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-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-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-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-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.