EASYTRAK® 3 IS-1 4550Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00802526420511), received between Jul 14, 2016 and Feb 7, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Adverse 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: Sepsis; Unspecified Infection

  MAUDE report 8314452 ↗
• InjuryJul 14, 2016Pacing Problem; Device Dislodged or Dislocated; Pacing Problem; Device Dislodged or Dislocated

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THERE WAS PACING THERAPY THAT WAS NOT DELIVERED WHEN REQUIRED. AN INVASIVE PROCEDURE WAS PERFORMED TO EXPLANT AND REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5795510 ↗

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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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-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-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-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-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-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.