BEUDAMED
    FDA Recall Open, Classified

    Imager II 5F Angiographic Catheters, 5 units per package.

    Recall: Z-1555-2020 · Initiated February 11, 2020

    Recall

    Recall Number
    Z-1555-2020
    Event Number
    84886
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Open, Classified
    Root Cause
    Environmental control
    Initiated
    February 11, 2020
    Posted
    March 25, 2020
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Imager II 5F Angiographic Catheters, 5 units per package.

    Reason

    Potential for tip detachment of Imager II 5F Angiographic Catheters

    Action

    Boston Scientific notified customers on about 02/11/2020 via "Urgent Medical Device Removal" letter. Customers were informed that Boston Scientific has noticed an increase in the rate of tip detachment complaints involving the recalled devices. Instructions included to examine inventory and quarantine affected products, complete and return the Verification Form, return all affected devices to Boston Scientific, and notify customers if affected devices were further distributed. An expansion letter was dated 08/06/2020 to include all batches/lots of the BSC Imager II Angiographic Catheter - 5 French Curved Tip Shapes.

    Distribution

    Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.

    Quantity

    1068827 Single Units