BEUDAMED
    FDA Recall Terminated

    804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

    Recall: Z-2554-2011 · Initiated May 16, 2011

    Recall

    Recall Number
    Z-2554-2011
    Event Number
    58762
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 16, 2011
    Posted
    June 14, 2011
    Terminated
    March 21, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

    Reason

    Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-house inspection after Terumo CVS implemented a new inspection process for the cannula. There have been no reports of the defect in clinical use.

    Action

    Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE REMOVAL notice dated May 16, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken. The letter described the problem, the potiential hazard, and the action to be taken by the consignee. Consignees were instructed to discontinue use of the product and return all product to Terumo. The letter provided a list of alternate products to be used instead of the recalled products. Consignees with questions should call 1-800-521-2818 Monday through Friday 8AM to 6PM.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.

    Quantity

    900