BEUDAMED
    FDA Recall Open, Classified

    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)

    Recall: Z-2352-2024 · Initiated May 10, 2024

    Recall

    Recall Number
    Z-2352-2024
    Event Number
    94779
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 10, 2024
    Posted
    July 12, 2024
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)

    Reason

    Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 05/10/2024 electronically (DocuSign) to each listed physician. For Physicians that do not have an email address or a DocuSign account, the Consignee Notification and Customer Confirmation Form were sent via mail UPS/USPS. The notice explained the issue, provided clinician and patient recommendations, and requested that the notice be shared with all those to whom the devices was transferred. If you have any questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative. On 03/12/2025, Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via mail. The Consignee Notifications informs the customer of availability of Ascenda catheters with the new design and requests the return of Ascenda catheters that were manufactured prior to the design update of 05/10/2024, and requested that the notice be shared with all those to whom the devices was transferred. For questions, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Iran, Islamic Republic, Iraq, Ireland, Jordan, Kazakhstan, Korean Republic of, Kuwait, Latvia, Lebanon, Lithuania, Libya, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherland, New Zealand, Norway, Oman, Panama, Pakistan, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirate, and United Kingdom.

    Quantity

    111762 units