EASYTRAK® 2 IS-1 4543 (UDI 00802526579813)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00802526579813), received between Apr 26, 2016 and Nov 25, 2025 — classified as 33 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED DUE TO UNKNOWN PRODUCT PERFORMANCE ANOMALY. SUBSEQUENTLY, IT WAS REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS LV LEAD INSULATION WAS COMPROMISED, THEN IT WAS REPLACED WITH A DIFFERENT MODEL LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647204 ↗
• InjuryJul 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD HAD BEEN TURNED OFF FOR A WHILE. AS OF THIS TIME, THIS LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566170 ↗
• MalfunctionNov 11, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WITH HIGH PACING THRESHOLDS. TECHNICAL SERVICES (TS) PROVIDED REPROGRAMMING OPTIONS. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658096 ↗
• InjuryNov 23, 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 SURGICALLY ABANDONED AND REPLACED DUE TO DIAPHRAGMATIC STIMULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18202214 ↗
• InjuryOct 17, 2023Failure to Capture; Fracture; High impedance; Defective Device; Failure to Capture; Fracture; High impedance; Defective Device

  IT WAS REPORTED THAT THERE WERE CONCERNS OF LEAD FRACTURE FOR THIS LEFT VENTRICULAR (LV) LEAD AS IT EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND FAILURE TO CAPTURE. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED CONFIRMATION ON THE FRACTURE. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949645 ↗
• InjuryJul 18, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO IT WAS EXHIBITING HIGH IMPEDANCE OUT OF RANGE MEASUREMENTS AFTER THE PLACEMENT OF THE NEW PULSE GENERATOR. NO ROOT CAUSE WAS DETERMINED SO IT WAS DECIDED TO REPLACE THE LEAD. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339946 ↗
• MalfunctionNov 9, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING IMPEDANCE VALUES OF GREATER THAN 3000 OHMS ON ALL TESTED VECTOR CONFIGURATIONS. PATIENT EXPERIENCED STIMULATION DURING LV LEAD VECTOR TESTING. IT WAS NOTED THAT PATIENT HAD AN ECHOCARDIOGRAM. TECHNICAL SERVICES (TS) ANALYZED PRESENTING ELECTROGRAM (EGM) AND FOUND THAT THERE WAS NO LOSS OF CAPTURE. SUBSEQUENTLY, TS PROVIDED TROUBLESHOOTING INCLUDING TESTING IMPEDANCES MEASUREMENTS ON OTHER VECTORS. LEAD REPLACEMENT WAS RECOMMENDED. PATIENT IS SCHEDULED FOR AN ECHOCARDIOGRAM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS LEAD REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 15759755 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7990222 ↗
• InjuryJul 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT EXPERIENCED TWIDDLER'S SYNDROME CAUSING THE LEFT VENTRICULAR (LV) LEAD TO GET DISLODGED. THE LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 7658339 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7622455 ↗
• InjuryApr 10, 2018Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD OBSERVATIONS OF HIGH PACING THRESHOLDS AND OUT OF RANGE HIGH PACING IMPEDANCES GREATER THAN 2000 OHMS. THE LEAD WAS EXPLANTED AND REPLACED, WHERE IT WAS OBSERVED THAT THE LEAD WAS FRACTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7411156 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7358319 ↗
• InjuryMar 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THE PATIENT WAS ALSO PUT ON INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7358160 ↗
• InjuryJan 17, 2018Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF HIGH PACING THRESHOLDS WAS DUE TO LEAD WAS PULLED BACK AND WAS CONFIRMED THROUGH FLUOROSCOPY. IN ADDITION, THE LARGE POSTERIOR LATERAL VESSEL WAS NOT A STABLE POSITION FOR THE LV LEAD. THIS LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7199376 ↗
• MalfunctionJan 16, 2018Failure to Capture; High impedance; Extracardiac stimulation; Use of Device Problem; Failure to Capture; High impedance; Extracardiac stimulation; Use of Device Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PLUGGED INTO THE RIGHT ATRIAL (RA) PORT. DURING IMPLANT ONE MONTH AGO, THE INITIAL LOCATION OF THE LV LEAD HAD STIMULATION AND LOSS OF CAPTURE. THE LEAD WAS REPOSITIONED PRIOR TO WOUND CLOSURE, WHERE THE FINAL LOCATION HAD IMPEDANCE VALUES OF 1890 OHMS. THE LV LEAD HAD NOW TRIGGERED A LEAD SAFETY SWITCH, AS THERE WAS HIGH OUT OF RANGE IMPEDANCE VALUES GREATER THAN 2000 OHMS. THE LEAD WAS IN UNIPOLAR, AND THE PLAN WAS TO INCREASE THE OUT OF RANGE LIMIT TO 3000 OHMS. LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Muscle Stimulation

  MAUDE report 7194069 ↗
• InjuryJan 16, 2018Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED ONE DAY AFTER IT WAS IMPLANTED DUE TO DISLODGEMENT. AT POST CHECK THERE WAS NO CAPTURE AT MAX OUTPUT. THE LEAD WAS NOT REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7193729 ↗
• InjuryOct 23, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS DISLODGED AS THE PATIENT MANIFESTED TWIDDLER'S SYNDROME. THE LV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 6969351 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 6938023 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION 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 6937828 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 6934232 ↗
• InjuryAug 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND OUT TO BE DISLODGED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT DISLODGEMENT WAS CONFIRMED DURING PREDISCHARGE CHECK OF THE PATIENT. THE LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6770162 ↗
• InjuryJul 20, 2017Fracture; High impedance; Fracture; High impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THISLEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENT GREATER THAN 2,500 OHMS. THERE WAS ALSO A REPORT THAT THERE WAS LEAD DAMAGE AS A RESULT OF SUB-CLAVIAN CRUSH. A REVISION PROCEDURE WAS PERFORMED AND THE LV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729861 ↗
• InjuryJul 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FOUND OUT TO BE DISLODGED. DISLODGEMENT WAS FOUND OUT THRU FLUOROSCOPY. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THERE WAS CLINICAL OBSERVATION KNOWN AS OF THIS TIME. THE LEAD WAS REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6718580 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO INFECTION AND SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 6717894 ↗
• InjuryJul 12, 2017Failure to Capture; High impedance; Capturing Problem; Failure to Capture; High impedance; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. SUBSEQUENT MEASUREMENTS WERE NOTED TO BE 1,000 TO 1,900 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6707730 ↗

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-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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• 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-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-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-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-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-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-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.