Events

Recall of Quadra Assura

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

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
    80212
  • Event Risk Class
    Class 2
  • Event Number
    Z-2324-2018
  • Event Initiated Date
    2018-04-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164888
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • Reason
    The firm is releasing new firmware for high voltage implantable cardiac devices (icd) and cardiac resynchronization therapy defibrillators (crt-d) intended to strengthen security by providing an additional layer of protection against unauthorized device access. for older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the rf communication capability in these devices.
  • Action
    On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.

Device

Quadra Assura
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide distribution
  • Product Description
    Quadra Assura, Sterile EO, Model #/ Part #: || CD3265-40/100042335, 100059846; || CD3265-40Q/100042336, 100059847; || CD3267-40/100042956, 100043569, 100059961, 100078810; || CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; || CD3365-40C/100080435, 100080436; || CD3365-40Q/100080426, 100080427; || CD3367-40/100078813, 100079497, 100096097; || CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; || CD3367-40Q/100078851, 100079212, 100079504, 100096098; || CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; || CD3385-40C/100080778; || CD3385-40QC/100080780, 100105489
  • Manufacturer
    St Jude Medical Inc.

Manufacturer

St Jude Medical Inc.
  • Manufacturer Address
    St Jude Medical Inc., 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