Events

Recall of Terumo Medical Corporation

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

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
    75370
  • Event Risk Class
    Class 2
  • Event Number
    Z-0669-2017
  • Event Initiated Date
    2016-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150185
  • 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
    Stent, superficial femoral artery - Product Code NIP
  • Reason
    During recent routine testing, the misago peripheral stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
  • Action
    Terumo Medical Corporation issued an Urgent Product Recall Bulletin dated August 4, 2016, via Fed Ex. Customers must immediately discontinue use and quarantine any available stock of the Misago peripheral stent to prevent further use. The customers should complete the enclosed Inventory Confirmation form as soon as possible and email or fax the completed form to misago.rc@terumomedical.com or (734) 330-2034, Attn: MISAGO Recall. Customers are encourage you to contact Terumo Medical Corporation with any questions or concerns -Terumo Medical Corporation Quality Department: 1.800.283.7866, Press 4 for list of departments, Press 7 for Quality Assurance; Monday  Friday, 8 a.m.  5 p.m. ET - Email Quality Assurance: misago.rc@terumomedical.com - Customer Care: 1.800.888.3786 - Contact your local Terumo representative

Device

Terumo Medical Corporation
  • Model / Serial
    150401 150429 150713 150821 150923 151009 160314  150413 150501 150708 150824 150915 151013 151111  150415 150515 150701 150716 150902 151005 151106  150407 150514 150707 150827 151008 151109 160509  150406 150501 150713 150716 150825 151001 151102 160315 160509 150410 150710 150831 150909 151007 151012 151014 151103 151208 150417 150429 150717 150910 151002 151102 160510  150408 150429 150701 150717 150831 151013 151103 160512  150409 150430 150518 150703 150706 150903 150914 151005  150331 150430 150708 150714 150904 150910 151001 151102  150414 150429 150715 150903 151005 151029 160323  150416 150518 150715 150908 150915 151002 151106 160328  150401 150430 150716 150828 151006  150403 150514 150717 150901 150909 151012  150408 150430 150713 150907 151001  150402 150512 150713 150907 151001
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    MISAGO RX Self Expanding Peripheral Stem
  • Manufacturer
    Terumo Medical Corp

Manufacturer

Terumo Medical Corp
  • Manufacturer Address
    Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA