BEUDAMED
    FDA Recall Terminated

    Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.

    Recall: Z-0763-06 · Initiated September 1, 2005

    Recall

    Recall Number
    Z-0763-06
    Event Number
    33341
    Firm
    Medtronic Cardiac Surgery Technologies
    FEI Number
    3003368396
    Product Code
    FZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2005
    Posted
    April 13, 2006
    Terminated
    April 1, 2007
    Address
    7601 Northland Dr N, Minneapolis, MN, 55428-1088

    Description

    Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis.

    Reason

    Customers stated that the U-Clip deployment collar was either difficult to rotate or 'locks up' during usage, which prevents the deployment of the U-Clips.

    Action

    A letter and response certificate disseminated to all customers describing problem and recommending return of Spyder devices in inventory. September 1, 2005.

    Distribution

    Nationwide (AZ, CA, CT, FL, HI, IA, ID, IL, IN, KS, KY, LA, ,MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, TN, TX, UT, WA, WI, WV). Japan, Belgium, Netherlands, Singapore, and Thailand.

    Quantity

    3383