BEUDAMED
    FDA Enforcement Class II Terminated

    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

    Recall: Z-2613-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2613-2016
    Event ID
    74010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    April 15, 2016
    Classification Date
    August 22, 2016
    Termination Date
    August 4, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques

    Reason

    Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

    Code Info

    All Lots. Catalog prefixes/suffixes SCBR5.5-/-SHTL SCBR6.5-/-SHTL Catalog/product number; Global/order number SCBR5.5-35-125-P-NS-H1-SHTL G31129 SCBR5.5-35-125-P-NS-JB1-SHTL G31130 SCBR5.5-35-125-P-NS-JB2-SHTL G36361 SCBR5.5-35-125-P-NS-MPA-SHTL G23697 SCBR5.5-35-125-P-NS-SIM1-SHTL G23699 SCBR5.5-35-125-P-NS-SIM2-SHTL G36360 SCBR5.5-35-125-P-NS-VERT-SHTL G23698 SCBR5.5-35-125-P-NS-VTK-SHTL G36359 SCBR5.5-35-135-P-NS-ANG-SHTL G48154 SCBR5.5-35-150-P-NS-0-SHTL G23705 SCBR5.5-35-150-P-NS-ANG-SHTL G23704 SCBR5.5-35-75-P-NS-ANG-SHTL G48152 SCBR6.5-35-125-P-NS-H1-SHTL G31134 SCBR6.5-35-125-P-NS-JB1-SHTL G31135 SCBR6.5-35-125-P-NS-JB2-SHTL G36364 SCBR6.5-35-125-P-NS-SIM1-SHTL G23701 SCBR6.5-35-125-P-NS-SIM2-SHTL G36363 SCBR6.5-35-125-P-NS-VERT-SHTL G23700 SCBR6.5-35-125-P-NS-VTK-SHTL G36362

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.

    Quantity

    60,302