Events

Recall of Device Recall Medtronic Racer Biliary Stent System

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
    53126
  • Event Risk Class
    Class 2
  • Event Number
    Z-1802-2010
  • Event Initiated Date
    2009-07-30
  • Event Date Posted
    2010-06-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84710
  • 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
    catheter, biliary, diagnostic - Product Code FGE
  • Reason
    Mislabeling-- the incorrect instructions for use may have been included with this product.
  • Action
    The firm, Medtronic, Inc., sent an "URGENT- VOLUNTARY MEDICAL DEVICE RECALL" dated July 30, 2009, to custumers (Sales Representatives, to health care provider, patient, and risk manager, hospital administrator). The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to immediately segregate any Racer Biliary units from model number XD518YF (L#0000705315) in their possession to prevent inadvertent use. Medtronic, Inc., representative will contact the customer to review the labeling and retrieve the device should it be in their inventory. The customers are being ask to cooperate by providing the representative with access to the product. If you have any questions, please contact 707-566-1548.

Device

Device Recall Medtronic Racer Biliary Stent System
  • Model / Serial
    Lot number 0000705315, use by date April 4, 2010
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA and Greater China.
  • Product Description
    Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA. || Medical device system consisting of a balloon-expandable intraluminal stent premounted onto the balloon of an over the wire delivery catheter. The system as two radiopaque markers on the inner member and positioned to each side of the stent, to aid in the placement of the stent during fluoroscopy. The system is compatible with labeled guidewires. The device is provided sterile and pyrogenic. It is indicated for use in the palliation of malignant neoplasms in the biliary tree.
  • Manufacturer
    Medtronic CardioVascular

Manufacturer

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