BEUDAMED
    FDA Recall Terminated

    MISAGO RX Self Expanding Peripheral Stem

    Recall: Z-0669-2017 · Initiated August 4, 2016

    Recall

    Recall Number
    Z-0669-2017
    Event Number
    75370
    Firm
    Terumo Medical Corp
    FEI Number
    2243441
    Product Code
    NIP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 4, 2016
    Terminated
    October 19, 2017
    Address
    2101 Cottontail Ln, Somerset, NJ, 08873-1277

    Description

    MISAGO RX Self Expanding Peripheral Stem

    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 [email protected] 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: [email protected] - Customer Care: 1.800.888.3786 - Contact your local Terumo representative

    Distribution

    Nationwide

    Quantity

    7,965 units