BEUDAMED
    FDA Recall Terminated

    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.

    Recall: Z-0717-2020 · Initiated November 8, 2019

    Recall

    Recall Number
    Z-0717-2020
    Event Number
    84363
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    MCX
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    November 8, 2019
    Posted
    December 19, 2019
    Terminated
    March 24, 2021
    Address
    300 Boston Scientific Way, Marlborough, MA, 01752-1291

    Description

    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.

    Reason

    Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.

    Action

    Boston Scientific Customer issued notification letters dated 11/08/19 via overnight mail delivery. Letter states reason for recall, health risk and action to take: AngioJet Repaired Consoles located at affected accounts will remain in the field. An AngioJet DFU will be provided to accounts to correct the previous DFU omission with the distribution of the Repaired Console. Your local Sales Representative can answer any questions that you may have regarding this correction. Please pass this notice to any healthcare professional from your organization who needs to be aware and to any organization where these devices have been transferred (if appropriate).

    Distribution

    Worldwide distribution - US Nationwide distribution and country of Canada.

    Quantity

    169 units ((OUS: 44 US: 125)