BEUDAMED
    FDA Enforcement Class II Terminated

    Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.

    Recall: Z-1302-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1302-2014
    Event ID
    67712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocardia, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2014
    Initiation Date
    March 3, 2014
    Classification Date
    March 27, 2014
    Termination Date
    June 19, 2014
    Address
    125 Shoreway Rd Ste B, N/A, San Carlos, CA, 94070-2718, United States

    Description

    Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.

    Reason

    Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

    Code Info

    Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186

    Distribution

    Worldwide Distribution: US (nationwide) and country of: Israel.

    Quantity

    ~2541 units - both catalog numbers.