BEUDAMED
    FDA Recall Terminated

    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

    Recall: Z-3136-2017 · Initiated July 13, 2017

    Recall

    Recall Number
    Z-3136-2017
    Event Number
    77976
    Firm
    Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland
    FEI Number
    3002806434
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 13, 2017
    Posted
    September 20, 2017
    Terminated
    August 19, 2020

    Description

    Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

    Reason

    Stylette removal difficulties on the Euphora and Solarice products.

    Action

    Medtronic sent a communication informing their consignees about the recall and for the customers to take the following actions: Medtronics records indicate that your facility has received product potentially affected by this issue. As a result, Medtronic requests that you immediately take the following actions: 1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected listed product in your inventory to Medtronic. Contact Medtronic Customer Service at 888-283-7868 to initiate a product return and credit. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to [email protected]. Medtronic is communicating this information to the U.S. FDA and other appropriate regulatory agencies as required. Please share this notification with others who need to be aware in your organization or to any organization where affected product may have potentially been transferred. We are committed to acting responsibly in the best interest of patient safety. We sincerely appreciate your patience as it relates to this matter. If you have any questions, please contact your Medtronic Field Representative or Technical Services at 1-877-526-7890 Ext. 27220. Adverse reactions or quality problems experienced with the use of this product may be reported to your Medtronic Representative and the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM

    Quantity

    69,081 (US)