Events

Recall of Silver Speed Hydrophilic Guidewire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EV3 Neurovascular.

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
    37821
  • Event Risk Class
    Class 2
  • Event Number
    Z-0839-2007
  • Event Initiated Date
    2007-04-05
  • Event Date Posted
    2007-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51634
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    vascular catheter guidewire - Product Code MKI
  • Reason
    Two customer complaints were received from physicians in japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
  • Action
    A recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires.

Device

Silver Speed Hydrophilic Guidewire
  • Model / Serial
    US: Lot # : 2295725; 2382836; 2355074; 2390635; 2348116; 2355074; 2374619; 2216295; 2257803;2390635; 2342166; ;2390635;2348116; 2310664; 2382836; 2257803; 2216295; 2310664; 2390635; 2247199; 2247200; 2221847; 2247200; 2295725; 2310664; 2221845; 2310664; 2216296; 2257803; 2342166;   European Union & Rest-Of-World Lot #:  2374619 ; 2209708;2216295; 2247200; 2310664; 2348116; 2221845 ; 2355074; 2247200; 2310664; 2216295; 2166877; 2247199; 2209708; 2367901; 2370509; 2374619; 2216295; 2163496; 2174470; 2295725; 2370509; 2376907; 2209708; 2295725; 2310664; 2221845; 2247200; 2216291; 2390635; 2360938; 2370509; 2376907; 2310664; 2355074; 2163496; 2276405; 2370508; 2221847; 2257803; 2390635; 2257803; 2370509; 2200727;
  • Product Classification
    Cardiovascular Devices
  • Distribution
    Worldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and United Arab Emirates
  • Product Description
    Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
  • Manufacturer
    EV3 Neurovascular

Manufacturer

EV3 Neurovascular
  • Manufacturer Address
    EV3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-2054
  • Source
    USFDA