Events

Recall of Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St Jude Medical Cardiac Rhythm Management Division.

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
    70066
  • Event Risk Class
    Class 2
  • Event Number
    Z-0949-2015
  • Event Initiated Date
    2014-12-18
  • Event Date Posted
    2015-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132201
  • 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
    Pulse generator, permanent, implantable - Product Code NVZ
  • Reason
    Transmitter may initiate a software reset resulting in backup operation in some implanted st. jude medical radio frequency (rf) enabled implantable cardioverter assura, unify assura, and quadra assura icds and assurity and allure pacemakers.
  • Action
    The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.

Device

Device Recall Merlinhome RF Remote Monitoring Transmitter, Model EX1150, with software versions ...
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
  • Product Description
    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. || Usage:RF Remote Transmitter
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division

Manufacturer

St Jude Medical Cardiac Rhythm Management Division
  • Manufacturer Address
    St Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA