EASYTRAK® 2 IS-1 4543 (UDI 00802526410994)Recalls & reported problems

Summary

The FDA's MAUDE database contains 727 adverse event reports that list this exact device (DI 00802526410994), received between Apr 9, 2012 and Sep 24, 2026 — classified as 5 deaths, 598 injuries, 124 malfunctions.

The most frequently reported specific device problem is “High impedance” (255 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 727 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Insufficient Device Problem Information; High Capture Threshold

  It was reported that this left ventricular (LV) lead was surgically abandoned due to an unknown product anomaly. A new lead was successfully implanted. No additional adverse patient effects were reported. This LV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885206 ↗
• InjurySep 14, 2026High impedance; Material Integrity Problem

  It was reported that this left ventricular (LV) lead exhibited high out of range pacing impedance measurements. It was later discovered this LV lead was fractured. The cause and location of the fracture on the lead are unknown. Subsequently, this LV lead was surgically abandoned and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756331 ↗
• InjurySep 4, 2026Insufficient Device Problem Information; High Capture Threshold

  It was reported that this left ventricular (LV) lead was surgically abandoned due to an unknown product performance issue. This LV lead was successfully replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602093 ↗
• MalfunctionAug 14, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246164 ↗
• InjuryJul 8, 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 25756473 ↗
• InjuryMay 18, 2026Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS CUT UPON REMOVAL. THIS LV LEAD WAS EXPLANTED, REPLACED WITH DIFFERENT MODEL AND WILL NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25200035 ↗
• InjuryMay 12, 2026Fracture; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A RISE AND THEN A SUDDEN JUMP OF PACING IMPEDANCE MEASUREMENTS REACHING HIGHER THAN 3000 OHMS. ADDITIONALLY, IT WAS NOTED THIS LEAD WAS FRACTURED. THIS LV LEAD WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156228 ↗
• MalfunctionMay 1, 2026High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT IT APPEARED THE THRESHOLD HAD DROPPED WHEN THE IMPEDANCE WENT UP. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED CONDUCTING TESTING IN PERSON. THIS LV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056729 ↗
• InjuryApr 27, 2026High impedance

  IT WAS REPORTED THAT THIS SYSTEM WITH A LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED UNSTABLE PACING IMPEDANCES (PI) THAT HAVE REACHED HIGH, OUT OF RANGE VALUES. PATIENT FELT SHORTNESS OF BREATH AND SYNCOPAL WHEN PACING IMPEDANCE VALUES WERE OUT OF RANGE. THRESHOLDS WERE STABLE ON DAYS WHEN PI WAS OOR AND CHANNEL WAS ABSENT OF NOISE. PRESENTING ELECTROGRAMS UNCHANGED. IT WAS RECOMMENDED TO CONSIDER SERIAL IMPEDANCES WITH ISOMETRIC MOVEMENTS IF NOT PERFORMED YET AND EVALUATE RING CONFIGURATIONS. AS PATIENT IS NOT DEPENDENT AND RV STABLE, SO CAN CONTINUE TO MONITOR THE LV AND CRT-D THAT REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 25010333 ↗
• InjuryApr 22, 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 24960627 ↗
• MalfunctionApr 20, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS OUT OF RANGE AND LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED PALPITATIONS. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED ASSISTANCE. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Palpitations; Unspecified Heart Problem

  MAUDE report 24925717 ↗
• InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE ALLERGIC REACTION AND ITCHING ISSUE. REPORTEDLY, THE PATIENT HAD A SEVERE ITCHING AND ALLERGY PROBLEM DUE TO METAL MATERIALS OF THE PACEMAKER. THE PATIENT WAS THEN TRANSFERRED TO THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) GROUP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD REMAINS IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 24785515 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND POCKET EROSION. REPORTEDLY, THE PATIENT HAD A HOLE IN THE CHEST AND WAS HOSPITALIZED FOR A YEAR. THE PATIENT WAS THEN REFERRED TO WARRANTY DEPARTMENT AFTER THE FIRST CALL DUE TO THE ALLEGATION OF PAIN AND DISCOMFORT BUT WAS INFORMED THAT THE INFECTION, EROSION OR MIGRATION ISSUES WERE A KNOWN MEDICAL RISK OF IMPLANTED PRODUCTS, THEREFORE THE EXPLANTED PRODUCTS DID NOT MEET THE WARRANTY ELIGIBILITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Discomfort; Pain; Pocket Erosion; Unspecified Infection

  MAUDE report 24646500 ↗
• InjuryFeb 27, 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. THIS LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24470294 ↗
• InjuryFeb 23, 2026Failure to Capture; High Capture Threshold

  BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED THREE MONTHS POST IMPLANT DUE TO DIAPHRAGMATIC STIMULATION. AN EPICARDIAL LV LEAD WAS SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 17 YEARS LATER REPORTED THAT LV LEAD WAS ACTIVE IN THE PATIENT'S CURRENT CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM. THE PATIENT PRESENTED TO THE HOSPITAL DUE TO SYMPTOMS CONSISTENT WITH PHRENIC NERVE STIMULATION (PNS) DESCRIBED AS SMALL SHOCKS AND HICCUP TYPE SENSATIONS IN THE CHEST. A LOCAL FIELD REPRESENTATIVE WAS PAGED FOR FURTHER EVALUATION. THE FOLLOWING DAY, RIGHT ATRIAL (RA) LEAD LOSS OF CAPTURE (LOC) WAS NOTED. SINUS ARREST WAS SUSPECTED DUE TO NO SENSING OF P-WAVES WITH RA SENSITIVITY AT 0.15 MV. ADDITIONALLY, THERE WAS INTERMITTENT LEFT VENTRICULAR (LV) LEAD LOC WITH A LV THRESHOLD MEASUREMENT OF 3.5 V @ 2.0 MS. LV OUTPUT WAS 3.5 V @ 2.0 MS, AND ALL OTHER VECTORS SHOWED THRESHOLD MEASUREMENTS GREATER THAN 5 V. ULTIMATELY, THE PHYSICIAN CHOSE TO PROGRAM THE CRT-P TO VVIR 60 BEATS PER MINUTE (BPM) AND RIGHT VENTRICULAR (RV) ONLY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINUS ARREST WAS CONFIRMED

  Patient problems: Asystole; Device Overstimulation of Tissue

  MAUDE report 24420875 ↗
• InjuryFeb 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS MISPLACED. THE LV LEAD WAS EXPLANTED, AND A NEW LEAD OF A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389227 ↗
• InjuryFeb 11, 2026Fracture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO FRACTURED. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319040 ↗
• MalfunctionJan 26, 2026High impedance

  IT WAS REPORTED THAT WHEN THIS PATIENT WAS GOING TO BE PROGRAMMED INTO MRI PROTECTION MODE THE LEFT VENTRICULAR (LV) LEAD PACE IMPEDANCES WERE FOUND TO BE HIGH OUT OF RANGE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185270 ↗
• InjuryJan 23, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24166444 ↗
• InjuryJan 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131883 ↗
• MalfunctionJan 15, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED HIGH PACING IMPEDANCE OUT OF RANGE (OOR) MEASUREMENTS ON THE LEFT VENTRICULAR (LV) LEAD, WHICH TRIGGERED TO LEAD SAFETY SWITCH (LSS) FROM BIPOLAR TO UNIPOLAR MODE. NO EVIDENCE OF LEAD NOISE AND IT WAS NOTED THAT THE MEASUREMENTS HAD BEEN STABLE IN THE RANGE. CLINICIAN WILL BRING THE PATIENT IN FOR FURTHER EVALUATION. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086273 ↗
• InjuryJan 5, 2026Signal Artifact/Noise; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS OUT OF RANGE, NOISY SIGNALS AND LOSS OF CAPTURE (LOC) ON THE LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND SUSPECTED THIS TO BE A LEAD ISSUE. TS WAS CONSULTED AND CLARIFIED THAT TURNING THIS LV OFF WOULD NOT IMPACT TACHYCARDIA THERAPY. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS LV WAS PROGRAMMED OFF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS LV WAS CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955037 ↗
• MalfunctionDec 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD RECEIVED A CALL FROM THE PREVIOUS CLINIC AND WAS INFORMED ABOUT POSSIBLE CORROSION ON DEVICE WIRES. THE PATIENT EXPRESSED CONCERN BECAUSE A DEVICE CHECK WAS COMPLETED AT A DIFFERENT FACILITY THE PREVIOUS WEEK, AND ALL RESULTS WERE NORMAL. A CLARIFICATION WAS REQUESTED REGARDING WHY BOSTON SCIENTIFIC CONTACTED THE PREVIOUS CLINIC. TO DATE, THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771262 ↗
• MalfunctionDec 4, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD RECORDED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS DURING AN IN-CLINIC VISIT. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND RECOMMENDED THE LV LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.ADDITIONAL INFORMATION WAS PROVIDED THAT THIS LV LEAD POTENTIALLY EXHIBITED LOSS OF CAPTURE (LOC), TS INDICATED THAT ALL LV PACING VECTORS HAD FAILED CAPTURE TESTING, AND AN ATTEMPTED LEAD AND SYSTEM REVISION PROCEDURE WAS UNSUCCESSFUL DUE TO VENOUS OCCLUSION, FOLLOWED BY AN UNSUCCESSFUL ATTEMPT AT ALTERNATIVE PACING. SUBSEQUENT DEVICE INTERROGATION DEMONSTRATED NO CAPTURE IN THE LV TIP-TO-RING CONFIGURATION WITH HIGH IMPEDANCE, WHILE SUCCESSFUL LV CAPTURE WAS ACHIEVED USING AN LV TIP-TO-RIGHT VENTRICULAR (RV) CONFIGURATION AT LOW OUTPUT. THE DEVICE WAS PROGRAMMED ACCORDINGLY, AND THE PATIENT WAS REPORTED TO BE RECOVERING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716789 ↗
• InjuryNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. THE LEAD HAS BEEN RECEIVED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669098 ↗

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-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-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-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-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-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-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-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.