BEUDAMED
    FDA Enforcement Class II Ongoing

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

    Recall: Z-1321-2021 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1321-2021
    Event ID
    87412
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    EPIX THERAPEUTICS, INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 7, 2021
    Initiation Date
    February 22, 2021
    Classification Date
    March 29, 2021
    Address
    945 Stewart Dr Ste 100, Sunnyvale, CA, 94085-3940, United States

    Description

    EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006

    Reason

    It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation, clots or air emboli.

    Code Info

    All Lots

    Distribution

    Product was not distributed in the US. OUS: Germany, Spain, France, Belgium, United Kingdom, Slovenia, Italy, Canada

    Quantity

    19 units