EASYTRAK 2 IS-1Recalls & reported problems across all models

We found 6 models of EASYTRAK 2 IS-1 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,332 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2012 and Sep 25, 2026 — classified as 8 deaths, 1,092 injuries, 232 malfunctions.

The most frequently reported specific device problem is “High impedance” (472 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 IS-1 problems

EASYTRAK 2 IS-1 models

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

• EASYTRAK® 2 IS-1 4543

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths727 reports
• EASYTRAK® 2 IS-1 4542

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths536 reports
• EASYTRAK® 2 IS-1 4543

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  36 reports
• EASYTRAK® 2 IS-1 4542

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  29 reports
• EASYTRAK® 2 IS-1 4544

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports
• EASYTRAK® 2 IS-1 4544

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

Recent EASYTRAK 2 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 25, 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 abandoned.

  Patient problems: Unspecified Infection

  MAUDE report 50897173 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 14, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246164 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports