Events

Recall of Device Recall Medtronic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic CardioVascular.

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
    46353
  • Event Risk Class
    Class 2
  • Event Number
    Z-0689-2008
  • Event Initiated Date
    2007-12-10
  • Event Date Posted
    2008-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67275
  • 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
    Endovascular Stent - Product Code MIH
  • Reason
    Sterility compromised: device sterility may be compromised as evidenced by a loss of outer package integrity.
  • Action
    Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.

Device

Device Recall Medtronic
  • Model / Serial
    All codes
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; || Model Numbers Affected: All AAAdvantage models including: || AEXC202040, IEXC121255, ILXC1212115, ILXC151585, || AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, || AEXC242440, IEXC141455, ILXC121285, ILXC1616135, || AEXC262640, IEXC151555, ILXC1313115, ILXC161685, || AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, || BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, || BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, || BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, || BFXC2213165, IEXC182485, ILXC141485, ILXC181885, || BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, || BFXC2414165, ILXC1515135, ILXC1822135, || BFXC2615135, ILXC1824115, || BFXC2615165, ILXC1824135, || BFXC2816135, ILXC2020115, || BFXC2816165, ILXC2020135, || ILXC202085; || Product is manufactured and distributed by Medtronic, Inc., Santa Rosa, CA 95403
  • Manufacturer
    Medtronic CardioVascular

Manufacturer

Medtronic CardioVascular
  • Manufacturer Address
    Medtronic CardioVascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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