Events

Recall of Protg "GPS" SelfExpanding Biliary Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ev3, 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
    57112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0626-2011
  • Event Initiated Date
    2010-10-30
  • Event Date Posted
    2010-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95413
  • 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
    Mislabeled size: specific prot¿g¿ gps lots have product labeling that does not match the actual stent sizes contained in the packages. the affected product outer packaging is labeled as a 12 mm x 60 mm prot¿g¿ gps stent but contains a 14 mm x 60 mm stent. this situation can potentially result in vessel damage. conversely, a lot was labeled as a 14 mm x 60 mm prot¿g¿ gps stent but actually contai.
  • Action
    ev3 issued a "Medical Device Recall" letter dated September 29, 2010 to consignees. The letter described the product, Issue Summary, & Required Action. Consignees are to review inventory and remove all affected devices. ev3 representatives will contact customers to arrange for the return and credit of unused product. ev3 can be reached at 800 716-6700 concerning this recall.

Device

Protg "GPS" SelfExpanding Biliary Stent System
  • Model / Serial
    Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80).
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution: including the states of AZ, DE, C, FL, GA, ID, IL, IN,LA, MN, MO, NJ, NY, NC, OH, VA, and WA.
  • Product Description
    ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only. || ev3 Inc. 4600 Nathan Lane, Plymouth, MN Prot¿g¿ " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only.
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Manufacturer Address
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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