BEUDAMED
    FDA Recall Terminated

    SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. for cardiovascular use

    Recall: Z-2646-2019 · Initiated March 15, 2019

    Recall

    Recall Number
    Z-2646-2019
    Event Number
    82525
    Firm
    Medtronic Vascular
    FEI Number
    1220452
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 15, 2019
    Posted
    October 1, 2019
    Terminated
    April 26, 2024
    Address
    35 Cherry Hill Dr, # 37a, Danvers, MA, 01923-2565

    Description

    SHERPA NX ACTIVE GUIDING CATHETER, 6F MB1, .070", REF SA6MB1. for cardiovascular use

    Reason

    There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

    Action

    Medtronic initiated immediate communications to consignees on 15-Mar-2019. Consignees were asked to quarantine and/or return unused affected product, and confirmation of the immediate notification was requested per local requirements. In the US, Medtronic representatives notified consignees. Consignees were asked to return a Customer Confirmation Certificate. On 11-Apr-2019, Medtronic initiated the US follow up communications via hand-delivery and UPS 2-day delivery mailings to the March 2019 notification consignees and risk managers identified as part of the April 2019 scope expansion. Consignees are asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-May-2019, Medtronic initiated additional communications via UPS 2-day delivery to 23 consignees in the US who were mailed the April 2019 notification with inaccurate product inventory reports. This communication included updated customer inventory reports. Communication was also initiated via UPS 2-day delivery to one consignee who did not receive the April 2019 notification, but did receive affected product. The consignees were asked to quarantine and return unused affected product. The consignees are asked to return a confirmation form, acknowledging they have received the notification and have taken the requested action. Beginning 10-Jun-2019, communication and retrieval activities will be initiated with all consignees who have received affected product (original and expanded scope) according to Medtronic records. Consignees will be asked to quarantine and return all unused affected product within their possession. Consignees will be asked to confirm receipt of this June 2019 FCA notification even if they have already confirmed notification of previous communications.

    Distribution

    Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

    Quantity

    492 units