BEUDAMED
    FDA Recall Completed

    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

    Recall: Z-1257-2021 · Initiated February 11, 2021

    Recall

    Recall Number
    Z-1257-2021
    Event Number
    87329
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    NIM
    Status
    Completed
    Root Cause
    Process control
    Initiated
    February 11, 2021
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

    Reason

    Distal tip may become separated from the lumen wire in specific lots.

    Action

    The firm initiated the recall by letter on 02/11/2021. The letter explained the reason for recall and potential impact to the patient, along with the request to further disseminate the notices and return of the recalled units.

    Distribution

    US (except MT and NM) and Taiwan

    Quantity

    18218 units