EASYTRAK 2Recalls & reported problems across all models

We found 2 models of EASYTRAK 2 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 255 adverse event reports in the FDA's MAUDE database, received between Jan 23, 2013 and Sep 24, 2026 — classified as 1 death, 200 injuries, 54 malfunctions.

The most frequently reported specific device problem is “High impedance” (82 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EASYTRAK 2 problems

EASYTRAK 2 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EASYTRAK® 2 4518

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death180 reports
• EASYTRAK® 2 4517

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  75 reports

Recent EASYTRAK 2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25026004 ↗
• 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 ↗
• MalfunctionJul 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FRACTURED. THE PHYSICIAN DID NOT WANT TO MAKE ANY CHANGES YET. TO DATE, THIS LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22431640 ↗
• 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 ↗
• InjuryMay 6, 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21969558 ↗

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