BEUDAMED
    FDA Enforcement Class II Terminated

    Morph AccessPro Steerable Introducer; 6F Introducer, 45 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-1301-2014 · Reported April 2, 2014

    Enforcement

    Recall Number
    Z-1301-2014
    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, 45 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 MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190

    Distribution

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

    Quantity

    ~2541 - both models