BEUDAMED
    FDA Recall Terminated

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    Recall: Z-1976-2021 · Initiated April 28, 2021

    Recall

    Recall Number
    Z-1976-2021
    Event Number
    88028
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3005364322
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 28, 2021
    Terminated
    April 5, 2024
    Address
    3850 Brickway Blvd, Santa Rosa, CA, 95403-8223

    Description

    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.

    Reason

    Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.

    Action

    Beginning on 04/28/2021, the Recalling Firm initiated a verbal notification and retrieved affected product for a single U.S. customer. On 05/10/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery to inform its impacted customer that the Recalling Firm has determined that the stent graft system was manufactured with an incorrect stentstop assembly. The letter was also to to ask for confirmation that the customer no longer had the affected devices in its possession. The letter instructed customers to take the following actions: 1. Complete the enclosed Customer Confirmation Form and email to [email protected]. 2. Forward this notice to all those who need to be aware within your organization. If there are any questions - contact the Recalling Firm's Field Representative.

    Distribution

    U.S. Nationwide distribution in the state of GA. O.U.S.: None

    Quantity

    3 devices