BEUDAMED
    FDA Enforcement Class II Ongoing

    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

    Recall: Z-2949-2020 · Reported September 16, 2020

    Enforcement

    Recall Number
    Z-2949-2020
    Event ID
    85822
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2020
    Initiation Date
    June 10, 2020
    Classification Date
    September 10, 2020
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

    Reason

    One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

    Code Info

    All lots.

    Distribution

    U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.

    Quantity

    67 units