BEUDAMED
    FDA Recall Terminated

    Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.

    Recall: Z-2333-2008 · Initiated January 29, 2008

    Recall

    Recall Number
    Z-2333-2008
    Event Number
    48678
    Firm
    Oscor, Inc.
    FEI Number
    1035166
    Product Code
    DTB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 29, 2008
    Posted
    September 24, 2008
    Terminated
    November 14, 2008
    Address
    3816 De Soto Blvd., Palm Harbor, FL, 34683-1618

    Description

    Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.

    Reason

    The O-rings are over tolerance making it hard to connect the leads to the pacemaker.

    Action

    On January 24, 08, Oscor sent out a letter to doctors/ customers with the subject line of "Re: Market Withdrawal of Permanent Pacing Leads due to the lead connector insertion difficulty," stating they experienced some difficulties with the insertion of pacing lead connectors into the pacemaker headers. They asked that customers review the inventory list and remove all products, whose serial numbers match the serial numbers on the list and have not been implanted. Also, customers should call Oscor customer service for a Return Goods Product number and return the product back to the firm for replacement.

    Distribution

    Nationwide Distribution