EASYTRAK® 2 IS-1 4542 (UDI 00802526410901)Recalls & reported problems

Summary

The FDA's MAUDE database contains 536 adverse event reports that list this exact device (DI 00802526410901), received between Jul 6, 2015 and Sep 17, 2026 — classified as 3 deaths, 429 injuries, 104 malfunctions.

The most frequently reported specific device problem is “High impedance” (202 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 536 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Capture; High impedance; High Capture Threshold

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and left ventricular (LV) lead exhibited pacing impedance measurements that were high and out of range, as well as loss of capture (LOC). It was noted that evaluation of the LV lead for possible replacement was planned. The patient was programmed to right ventricular (RV) only pacing. This CRT-D and LV lead remain in service. No adverse patient effects were reported.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 50797943 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this left ventricular (LV) lead was surgically abandoned due to an unknown reason. A new lead was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336820 ↗
• InjuryAug 11, 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 infection with sepsis. The patient was treated with intravenous antibiotics. There was no additional adverse patient effects reported. The LV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50208517 ↗
• MalfunctionJun 30, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED A SUDDEN RISE ON PACING IMPEDANCE MEASUREMENTS, REACHING HIGH OUT OF RANGE VALUES GREATER THAN 3000 OHMS ON THE LEFT VENTRICULAR (LV) CHANNEL. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING ENHANCEMENTS. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673608 ↗
• MalfunctionJun 25, 2026Failure to Capture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD FRACTURED AND WAS CONCERNED ABOUT POTENTIAL LOSS OF CAPTURE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND WAS UNABLE TO DETERMINE IF THE LV LEAD WAS TRULY CAPTURING OR NOT. THEREFORE, TS RECOMMENDED THAT THE PATIENT BE EVALUATED IN-CLINIC TO ENSURE ADEQUATE CAPTURE. AT THIS TIME, THIS LV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630314 ↗
• InjuryJun 24, 2026High impedance

  It was reported that this left ventricular (LV) lead exhibited a high out of range pacing impedance, greater than 3000 Ohms. It was noted the patient had some other medical issues. No LV vectors were viable, subsequently, this LV lead was programmed off. This LV lead remains in situ. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610801 ↗
• InjuryJun 10, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25463909 ↗
• InjuryMay 18, 2026Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, THE CRT-D WAS EXPLANTED AND REPLACED, WHILE THE LV REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211814 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25208744 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PREVIOUSLY CAPPED LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25111166 ↗
• InjuryApr 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 SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 25043202 ↗
• InjuryApr 29, 2026Fracture; High impedance

  IT WAS REPORTED THAT THIS LV LEAD EXHIBITED AN IMPEDANCE MEASUREMENT OF MORE THAN 3000 OHMS DUE TO VISIBLE CONDUCTOR CABLE FRACTURE WHICH WAS OBSERVED IN THE POCKET. THIS LV LEAD WAS SURGICALLY ABANDONED AND REPLACE WITH A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027826 ↗
• InjuryApr 22, 2026Failure to Capture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO FRACTURE AND NO CAPTURE. A NEW LEAD WITH DIFFERENT MODEL WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957400 ↗
• InjuryApr 22, 2026Failure to Capture; High impedance; Material Integrity Problem; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956112 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PREVIOUSLY CAPPED LEFT VENTRICULAR (LV) LEAD HAD AN INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED LV LEAD REMAINS CAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 24551816 ↗
• InjuryMar 6, 2026Use of Device Problem; Connection Problem

  IT WAS REPORTED THAT INTERROGATION OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS UNSUCCESSFUL, AND THIS CRT-D HAD REACHED THE EXPLANT INDICATOR IN (B)(6) 2024. REVIEW OF DEVICE SETTINGS NOTED LOW OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS FOR MORE THAN A YEAR ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH WAS PURPOSEFULLY CONNECTED TO THE LEFT VENTRICULAR (LV) PORT AT THE LAST DEVICE REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RV LEAD IMPEDANCE ISSUE WAS KNOWN AT THE PREVIOUS DEVICE CHANGEOUT, AND THE RV AND LV LEADS WERE PURPOSEFULLY SWITCHED IN THE HEADER DURING THE BATTERY REPLACEMENT PROCEDURE FOR THIS REASON. AT THIS TIME, THERE ARE NO OTHER PLANS FOR INTERVENTION, OTHER THAN THE UPCOMING BATTERY REPLACEMENT. THIS LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537246 ↗
• InjuryMar 4, 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 INFECTION AND EROSION. THE SYSTEM WAS REPORTEDLY PLANNED FOR EXPLANT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 24513186 ↗
• MalfunctionFeb 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT, IT WAS OBSERVED THAT THE INSULATION OF THE IMPLANTABLE LEAD HAD SUSTAINED DAMAGE DUE TO AN ACUTE BEND IN THE LEAD. DESPITE THIS FINDING, ALL LEAD FUNCTIONS WERE STABLE. THE PHYSICIAN OPTED TO RETAIN THE EXISTING LEAD AND WILL MONITOR FOR ANY FUTURE COMPLICATIONS. THE PATIENT IS SCHEDULED FOR REGULAR FOLLOW-UP APPOINTMENTS. THE LEAD REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311529 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Material Integrity Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED NOISY SIGNALS, CROSSTALK OVERSENSING, OUT OF RANGE PACING IMPEDANCES WITH MEASUREMENTS GREATER THAN 3000 OHMS, AND LOSS OF CAPTURE. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DATA AND CONFIRMED THESE OBSERVATIONS. TS ALSO NOTED THAT THE HEADER HAS THE LATEST ENHANCEMENTS DESIGNED TO MINIMIZE SPRING CONTACT RELATED ISSUES, MAKING A CONNECTION PROBLEM UNLIKELY. FURTHER IN CLINIC EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036205 ↗
• InjuryJan 5, 2026Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS. THRESHOLD AT 7.5 VOLTS SHOWED NO CAPTURE. TECHNICAL SERVICES (TS) NOTED IT SOUNDED LIKE THIS LV LEAD WAS NOT FUNCTIONING AND HAD THE HEALTH CARE PROFESSIONAL (HCP) PROGRAM THE DEVICE TO RIGHT VENTRICULAR (RV) ONLY AS THERE WERE MINIMUM LV OUTPUTS, BIVENTRICULAR PACING OFF AND DAILY MEASUREMENTS OFF. THIS LV LEAD REMAINS IMPLANTED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957002 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23858445 ↗
• InjuryDec 2, 2025Adverse 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 A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PREVIOUSLY CAPPED LV LEAD REMAINS CAPPED.

  Patient problems: Unspecified Infection

  MAUDE report 23698381 ↗
• InjuryNov 7, 2025Failure to Capture; Defective Device; Failure to Capture; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO A PRODUCT PERFORMANCE ISSUE. THE REPLACEMENT PROCEDURE WAS SUCCESSFULLY PERFORMED AND A NEW LEAD WAS IMPLANTED INSTEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LV LEAD WAS SURGICALLY ABANDONED DUE TO LOSS OF CAPTURE (LOC). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501507 ↗
• InjuryOct 31, 2025Defective Device; High Capture Threshold; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438662 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED MUSCLE STIMULATION. THE LEAD WAS LATER EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23423991 ↗

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-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-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-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-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-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.