BEUDAMED
    FDA Recall 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 · Initiated March 3, 2014

    Recall

    Recall Number
    Z-1301-2014
    Event Number
    67712
    Firm
    Biocardia, Inc.
    FEI Number
    3003610571
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2014
    Posted
    March 27, 2014
    Terminated
    June 19, 2014
    Address
    125 Shoreway Rd, Ste B, San Carlos, CA, 94070-2718

    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.

    Action

    The firm, BioCardia, Inc., sent an "URGENT-VOLUNTARY MEDICAL DEVICE RECALL" letter dated March 3, 2014 its customers, hospital's Director of Risk Management, via USPS mail and priority mail to Cardiac Catheterization Laboratory. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory; quarantine the product; return the product to BioCardia and contact Customer Service at 650-226-0148 to coordinate product return; in the event you no longer have this device as a result of further distribution, identify the purchaser and notify them at once of this recall; and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via FAX to 650-631-3731 or mail to: BioCardia, Inc., 125 Shoreway Road, Suite B, San Carlos, CA 94070 as soon as possible. If you have any questions, call the Vice President, Quality Assurance at 650-226-0143.

    Distribution

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

    Quantity

    ~2541 - both models