BEUDAMED
    FDA Recall Terminated

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    Recall: Z-1202-2017 · Initiated February 10, 2017

    Recall

    Recall Number
    Z-1202-2017
    Event Number
    76448
    Firm
    Abbott Vascular
    FEI Number
    2024168
    Product Code
    MGB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2017
    Terminated
    December 6, 2017
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    Reason

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.

    Action

    An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questions are instructed to contact their local Abbott Vascular Representative or Customer Service Department at (800) 227-9902.

    Distribution

    US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,

    Quantity

    170,008 units total (83,029 units in US)