Events

Recall of Power cord used on BioConsole, autoLog, Sequestra

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiovascular Revascularization & Surgical Therap.

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
    55749
  • Event Risk Class
    Class 2
  • Event Number
    Z-1939-2010
  • Event Initiated Date
    2010-04-21
  • Event Date Posted
    2010-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91714
  • 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
    power cord on cardiopulmonary bypass - Product Code DWA
  • Reason
    The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. although medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. this field notificatio.
  • Action
    Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.

Device

Power cord used on BioConsole, autoLog, Sequestra
  • Model / Serial
    Part # 66319 & 055476
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
  • Product Description
    Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: || Medtronic Bio-Console¿ 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. || Medtronic Bio-Console¿ 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. || Medtronic autoLog¿, Model # ATLG110, Catalogue # ATLG110, ATLG110E || ATLG110R. || Medtronic Sequestra¿ 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Manufacturer Address
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA