EASYTRAK 3Recalls & reported problems across all models
Boston Scientific Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 0
We found 3 models of EASYTRAK 3 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Jul 16, 2016 and Dec 30, 2025 — classified as 44 injuries, 5 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (12 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
Reports received per month, all models
Most reported EASYTRAK 3 problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- High Capture Threshold12
- Defective Device5
- High impedance5
- Failure to Capture4
- Device Dislodged or Dislocated3
- Material Integrity Problem2
- Difficult To Position1
Patient problems
- Unspecified Infection25
- No Code Available11
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient7
- Sepsis6
- No Consequences Or Impact To Patient4
- Erosion2
- Pocket Erosion2
EASYTRAK 3 models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EASYTRAK® 3 4525Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)30 reports
- EASYTRAK® 3 4524Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)18 reports
- EASYTRAK® 3 4527Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 report
Recent EASYTRAK 3 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS PREVIOUSLY CAPPED IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PREVIOUSLY CAPPED IMPLANTABLE LEAD WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23931624 ↗InjuryAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED DISLODGEMENT. THIS LV LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WITH A DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22869311 ↗InjuryAug 7, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLD. NO NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745375 ↗InjuryJun 12, 2025Defective Device; Defective Device
IT WAS REPORTED THAT PART OF THIS LEFT VENTRICULAR (LV) LEAD WAS BROKEN AND WAS STILL IN THE PATIENT CORONARY SINUS BRANCH. IN ADDITION, THE PATIENT WITH THIS LV LEAD EXPERIENCED INFECTION. THIS LV LEAD WAS SURGICALLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Foreign Body In Patient; Unspecified Infection
MAUDE report 22194067 ↗InjuryMay 28, 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 ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 22093739 ↗InjuryMay 8, 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 POCKET EROSION AND INFECTION. REPORTEDLY, THE PATIENT LOST A LOT OF WEIGHT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 21990792 ↗InjuryApr 20, 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 21870260 ↗InjuryDec 3, 2024Adverse 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 VEGETATION ON LEADS. THIS LEAD WAS EXPLANTED. IN ADDITION, THE PHYSICIAN ALSO PERFORMED ANGIOVAC PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Patient problems: Unspecified Infection
MAUDE report 20830694 ↗MalfunctionOct 28, 2024Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20547200 ↗InjuryMay 2, 2024Adverse 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 SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PREVIOUSLY CAPPED LV LEAD REMAINS SURGICALLY ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 19235553 ↗InjuryJan 1, 2024Adverse 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. THIS LV LEAD WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 18423191 ↗MalfunctionOct 3, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THERE WERE DIFFICULTIES GETTING THIS LEFT VENTRICULAR (LV) LEAD INTO THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) PROVIDED A RESOLUTION OPTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS LEAD ABLE TO BE CONNECTED TO THE HEADER OF THE DEVICE AFTER PUSHING THE LEAD IN HARDER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17859780 ↗InjuryJun 22, 2023High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183018 ↗InjuryJan 4, 2023Adverse 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 POCKET INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 16098727 ↗InjuryOct 25, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD EXHIBITED INFECTION. REPORTEDLY, WHILE PERFORMING RIGHT VENTRICULAR (RV) LEAD EXTRACTION, THE LEFT VENTRICULAR (LV) LEAD WAS FRACTURED AND THE COIL UNRAVELED; HENCE, THE LV LEAD WAS ABANDONED FOR THE TIME BEING. MOREOVER, WHILE PULLING OUT THE RIGHT ATRIAL (RA) LEAD, THE ANESTHESIOLOGIST NOTICED AN EFFUSION IN THE RIGHT ATRIUM AND THE PATIENT EXPERIENCED CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. SUBSEQUENTLY, AN OPEN-HEART PROCEDURE WAS DONE TO FIX THE EFFUSION. A REVISION WAS PERFORMED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WILL NOT BE RETURNED.
Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion; Unspecified Infection
MAUDE report 15671040 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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