Events

Recall of Cougar Nitinol Workhorse Guidewire

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

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
    66567
  • Event Risk Class
    Class 1
  • Event Number
    Z-0261-2014
  • Event Initiated Date
    2013-10-21
  • Event Date Posted
    2013-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122624
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Potential for ptfe (polytetrafluroethylene) coating to delaminate and detach from guidewire.
  • Action
    The firm, Medtronic, sent a "URGENT MEDICAL DEVICE RECALL" letter dated October 21, 2013 (in the US via UPS overnight service, 1-day delivery) to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove and quarantine all potentially affected guidewires that remain in inventory; return the affected product to Medtronic; if replacement product is needed, your Medtronic representative can assist you with identifying suitable replacement product, and to complete and return the Customer Confirmation Certificate confirming receipt of the notification via fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality (100% customer confirmations will be required). Should have any questions, please contact your Medtronic Representative or call 763-526-2513. Notifications to customers concerning the additional affected product began December 19, 2013 (in the US via UPS overnight service, 1-day delivery). Customers are requested to return a Confirmation Certificate confirming their receipt of the notification. 100% customer confirmations will be required from the additional consignees.

Device

Cougar Nitinol Workhorse Guidewire
  • Model / Serial
    G13A00104 G13A00105 G13A00106 G13A00107 G13A00108 G13A00109 G13A00110 G13A00112 G13A00113 G13A00114 G13A00692 G13A00713 G13A00734 G13A00788 G13A00803 G13A00804 G13A00809 G13A00810 G13A00811 G13A00874 G13A00971 G13A00972 G13A00973 G13A00974 G13A00975 G13A00976 G13A00977 G13A00978 G13A00979 G13A00980 G13A00981 G13A00982 G13A01016 G13A01017 G13A01330 G13A01400 G13A01401 G13A01409 G13A01410 G13A01411 G13A01446 G13A01449 G13A01452 G13A01569 G13A01584 G13A01600 G13A01604 G13A01605 G13A01606 G13A01607 G13A01608 G13A01609 GV827 GV829 GV830 GV831 GV832 GV835 GV836 GV837 GV838 GV839 GV840 GV844 GV845 GW405 GW406 GW407 GW508 GW509 GW510 GW675 GW687 GW688 GW706 GW710 GW745 GW746 GV824
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.
  • Product Description
    Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S || Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Manufacturer Address
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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