• Advocacy

     
     
     
    Type Size
     

    Boston Scientific, Maquet and Terumo Issue Recalls

    June 15, 2011

    The FDA announced three recalls this week affecting cardiovascular care. In addition to immediately discontinuing the use of these products and contacting the related companies, healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information online at www.fda.gov/MedWatch/report.htm.

    Here's more information on the individual recalls:

    1) Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters

    Boston Scientific has issued a recall notice for these catheters after finding that the catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.

    Read the Recall Notice


    2) Maquet Datascope Corp. Intra-Aortic Balloon Pumps

    Maquet Datascope Corporation has notified customers by letter of a defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

    Read the Recall Notice


    3) Terumo Coronary Ostia Cannula 10, 12, 14 Fr

    Terumo is advising customers that foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery. Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply.

    Read the Recall Notice