BEUDAMED
    FDA Recall Open, Classified

    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

    Recall: Z-1070-2025 · Initiated January 10, 2025

    Recall

    Recall Number
    Z-1070-2025
    Event Number
    96097
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    QCT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 10, 2025
    Posted
    February 14, 2025
    Address
    9965 Federal Dr, Colorado Springs, CO, 80921-3822

    Description

    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

    Reason

    Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

    Action

    On 1/10/2025, Philips mailed recall notices to customers informing them of the following: Firm will no longer distributed the device. Check your product inventory and quarantine any affected devices to prevent use. Do not open or use any products that have been identified within your inventory. Circulate this notice to all users of the device, or to any organization where the affected product may have been transferred, so they are aware of the product Recall. Complete and return the response form via email to [email protected]

    Distribution

    Distribution US nationwide and countries of: NL, DE, NL, AU, IT, CH, GB, and AT

    Quantity

    2,939