Events

Recall of Device Recall Ellipse and Ellipse ST ICDs

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
    69087
  • Event Risk Class
    Class 2
  • Event Number
    Z-2572-2014
  • Event Initiated Date
    2014-08-19
  • Event Date Posted
    2014-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129605
  • 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
    An anomaly may result in delayed, partial, or no delivery of high voltage therapy. internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. it may present as a vibratory patient notification and upon interrogation, a programmer or merlin.Net alert.
  • Action
    A customer letter dated 8/19/14 was sent to physicians with the affected Ellipse ICDs on 8/20/14. The letter identifies the problems and the actions to be taken. Customers with any questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medicals Technical Services Department.

Device

Device Recall Ellipse and Ellipse ST ICDs
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
  • Product Description
    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 || Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
  • 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