BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    Recall: Z-0757-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0757-2013
    Event ID
    60906
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    November 30, 2011
    Classification Date
    January 31, 2013
    Termination Date
    January 31, 2013
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630, United States

    Description

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    Reason

    The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.

    Code Info

    Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.

    Quantity

    1253 units (962 units in the US & Puerto Rico)