Events

Recall of Device Recall Complete SE Biliary Stent System, SC5120L (5 mm x 120 mm)

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
    53199
  • Event Risk Class
    Class 2
  • Event Number
    Z-0654-2010
  • Event Initiated Date
    2009-07-17
  • Event Date Posted
    2010-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84917
  • 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-- a lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
  • Action
    Medtronic, Inc. issued an "Urgent - Voluntary Medical Device Recall" communication dated July 17, 2009 asking consignees to segregate labeled lot numbers until a representative from the firm arrived to retrieve the products. For further information, contact your local Medtronic representative or call Medtronic, Inc. at 1-707-525-0111.

Device

Device Recall Complete SE Biliary Stent System, SC5120L (5 mm x 120 mm)
  • Model / Serial
    Lot Number: 0000983799, use by date 03/17/2011.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
  • Product Description
    Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. || 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