BEUDAMED
    FDA Enforcement Class II Terminated

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    Recall: Z-1102-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1102-2018
    Event ID
    79424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 28, 2018
    Initiation Date
    December 12, 2017
    Classification Date
    March 18, 2018
    Termination Date
    October 24, 2019
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN: 08714729008446 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors

    Reason

    Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.

    Code Info

    Expiration Date Range: 3/27/2018 9/25/2021; Batch: 16852983 18912864 20404111 16969146 18932466 20458384 16987703 19157072 20491745 17078511 19318043 20517724 17159358 19338399 20567074 17248134 19596298 20567075 17672818 19623064 20593962 17780452 19705478 20658862 17910342 19737920 20682997 17960225 19850692 20735792 17976830 19934631 20769252 18100917 20065714 20830243 18106456 20169834 20884298 18172896 20198263 20909294 18280357 20284828 21027051 18398908 20312727 21101918 18821698 20330766 21181528 18876334

    Distribution

    Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.

    Quantity

    2224