Events

Recall of Device Recall ENDOTAK RELIANCE SG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific CRM Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68700
  • Event Risk Class
    Class 2
  • Event Number
    Z-2147-2014
  • Event Initiated Date
    2014-06-19
  • Event Date Posted
    2014-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128470
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Reason
    A review of manufacturing test records for boston scientific endotak reliance implantable leads revealed a suspected test data recording error. specifically, some test results were recorded as "failed" without any other indication of failure. there are no reported injuries from the devices.
  • Action
    Sales representatives hand delivered a Boston Scientific "Medical Device Retrieval" Letter dated June 19, 2014 or June 20, 2014 when they were retrieving the devices from the hospital shelves. The letter was addressed to Hospital Administrator. The letter described the problem, product being recalled and the retrieval of the device by Boston scientific sales representative. For further questions they can contact their local sales representative or Boston Scientific International Technical Services. Physicians were contacted via telephone starting on July 6, 2014. A Boston Scientific letter dated July 8, 2014 followed the telephone conversation. For further information physicians can contact their local Boston Scientific representative or Technical Services at 1-800-227-3422.

Device

Device Recall ENDOTAK RELIANCE SG
  • Model / Serial
    Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
  • Product Description
    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. || Product Usage: || The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Manufacturer Address
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA