BEUDAMED
    FDA Recall Terminated

    Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

    Recall: Z-2418-2011 · Initiated March 28, 2011

    Recall

    Recall Number
    Z-2418-2011
    Event Number
    58405
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 28, 2011
    Posted
    June 10, 2011
    Terminated
    July 30, 2012
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

    Reason

    Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.

    Action

    Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications. The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation. Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific

    Distribution

    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.

    Quantity

    66,033