EASYTRAK 3 IS-1Recalls & reported problems across all models

We found 3 models of EASYTRAK 3 IS-1 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 191 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2014 and Sep 23, 2026 — classified as 150 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (47 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 3 IS-1 problems

EASYTRAK 3 IS-1 models

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

• EASYTRAK® 3 IS-1 4549

  Implantable pulse generator, pacemaker (non-CRT)
  135 reports
• EASYTRAK® 3 IS-1 4548

  Implantable pulse generator, pacemaker (non-CRT)
  54 reports
• EASYTRAK® 3 IS-1 4550

  Implantable pulse generator, pacemaker (non-CRT)
  2 reports

Recent EASYTRAK 3 IS-1 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50873323 ↗
• InjuryJun 9, 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 EROSION AND INFECTION. THE PATIENT EXPERIENCED EDEMA, INFLAMMATION AND SWELLING. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS CUT FROM THE TERMINAL PIN, AND THE LEAD BODY REMAINS IMPLANTED AND INACTIVE.

  Patient problems: Erosion; Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 25446893 ↗
• MalfunctionMay 21, 2026Failure to Capture

  IT WAS REPORTED THAT THERE WAS A CONCERN ABOUT POTENTIAL LOSS OF CAPTURE (LOC) ON THIS LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW OF PRESENTING ELECTROGRAM (EGM), DETERMINED THAT THIS LEAD EXHIBITED INTERMITTENT LOC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243950 ↗
• MalfunctionApr 15, 2026Failure to Capture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE ON THE PRESENTING ELECTROGRAM. THE HEALTH CARE PROFESSIONAL PROVIDED THE PATIENT WOULD BE SEEN IN CLINIC. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887427 ↗
• MalfunctionMar 25, 2026Low impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD RECORDED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND, WHILE THE MOST RECENT IN-OFFICE MEASUREMENT WERE WITHIN NORMAL LIMITS, LOW OUT OF RANGE VALUES WERE NOTED A FEW MONTHS PRIOR. SENSING AND PACING THRESHOLDS REMAINED STABLE. TS ADVISED THAT LOW IMPEDANCE VALUES MAY SUGGEST POTENTIAL INSULATION DEGRADATION AND CONTINUED MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684009 ↗
• MalfunctionJan 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) REGARDING STORED EPISODES ASSOCIATED. THE FACILITY INFORMED THIS LEFT VENTRICULAR (LV) LEAD HAD A KNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945567 ↗
• InjuryDec 11, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS AT 5.0 VOLTS AT 2.0 MILLI SECONDS. IN ADDITION, THE PATIENT WITH THIS LV WAS OCCLUDED ON THE LEFT SIDE. CONSEQUENTLY, THIS LV WAS SURGICALLY ABANDONED ALONG WITH DEVICE AND REPLACED WITH NON-BOSTON SCIENTIFIC MODELS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23779324 ↗
• MalfunctionDec 2, 2025Over-Sensing; Failure to Read Input Signal; Over-Sensing; Failure to Read Input Signal

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW THE PRESENTING ELECTROGRAM (EGM) ON THIS LEFT VENTRICULAR (LV) LEAD. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA, NOTED PREMATURE VENTRICULAR CONTRACTION (PVC) FOR SOME TIME AND WONDERED IF THERE IS EVIDENCE OF A POSSIBLE DISLODGMENT OR AN EXPERIENCED FALL. ADDITIONALLY, ALERTS OF LOW INTRINSIC AMPLITUDE OUT OF RANGE AND PACING PERCENTAGES BELOW THE PROGRAMMED THRESHOLDS WERE NOTED. THE PLAN IS TO CONTINUE TO MONITOR AND FURTHER EVALUATE IN AN IN-CLINIC VISIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LV LEAD SHOWED DEFLECTIONS THAT COULD BE POTENTIAL OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696773 ↗
• InjuryNov 27, 2025Extracardiac stimulation; Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD A DIAPHRAGMATIC STIMULATION BY THE ABDOMEN AND THUMPING IN ON THE CHEST AND REPROGRAMMING WAS MADE AND RESOLVED. HOWEVER, THE SYMPTOMS REOCCURRED. PATIENT WAS SUGGESTED TO HAVE THIS LV LEAD TURNED OFF. AS OF THIS TIME, THIS LV REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATES THAT LV LEAD IS STILL ON AND ACTIVE WITH NO STIMULATION AS OF THE PRESENT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23666175 ↗
• MalfunctionNov 18, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE (LOC). THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587375 ↗
• MalfunctionNov 13, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING OF THE ATRIAL EVENTS IN THE LV CHANNEL. THIS CAUSED A DECREASE IN THE LV PACING PERCENTAGE AND PACING INHIBITION. TECHNICAL SERVICES (TS) RECOMMENDED TURNING LV SENSING OFF AND TO BRING IN THE PATIENT TO ENSURE LEAD MEASUREMENTS WERE IN RANGE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THE OVERSENSING WAS CAUSED BY THE LEAD POSITION. THE PATIENT WAS NOT PACER DEPENDENT. LV SENSING WAS TURNED OFF AND IT WAS CONFIRMED LEAD MEASUREMENTS WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546604 ↗
• InjuryOct 24, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 23386399 ↗
• 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23088629 ↗
• InjuryAug 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS MOST OF THE TIME. TECHNICAL SERVICES (TS) REVIEWED NOTING LV THRESHOLDS ARE STABLE AND THAT THE LV SENSING IS PROGRAMMED OFF. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853850 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT VENTRICULAR (RV) LEAD EXTRACTION PROCEDURE, THE OUTER CONDUCTOR OF THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE FRACTURED. IT WAS FUNCTIONING OK IN UNIPOLAR AND WAS SUCCESSFULLY CAPTURING SO IT WAS LEFT AS IS. THIS WAS NOTED TO BE VISIBLE ON X RAY UNDER THE CLAVICLE. THE PROCEDURE CASE WAS 3 AND A HALF HOURS AND THE PHYSICIAN OPTED TO FINISH THE CASE. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669215 ↗

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