BEUDAMED
    FDA Recall Open, Classified

    Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP Pericardial Sump 38.1 cm (15 in), Model Number 12010,

    Recall: Z-1797-2024 · Initiated March 19, 2024

    Recall

    Recall Number
    Z-1797-2024
    Event Number
    94274
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DWF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 19, 2024
    Posted
    May 10, 2024
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP Pericardial Sump 38.1 cm (15 in), Model Number 12010,

    Reason

    Potential for unsealed sterile packing.

    Action

    Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

    Distribution

    Worldwide distribution.

    Quantity

    13954 units