Events

Recall of Device Recall Runthrough NS Guidewire

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

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
    59051
  • Event Risk Class
    Class 2
  • Event Number
    Z-2858-2011
  • Event Initiated Date
    2011-06-03
  • Event Date Posted
    2011-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100937
  • 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
    Baloon catheter guidewires may become uncoiled during angioplasty procedures.
  • Action
    Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.

Device

Device Recall Runthrough NS Guidewire
  • Model / Serial
    Lot 101028, exp 2013 - 09
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
  • Product Description
    Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH || Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)
  • Manufacturer
    Terumo Medical Corporation

Manufacturer

Terumo Medical Corporation
  • Manufacturer Address
    Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA