BEUDAMED
    FDA Recall Terminated

    Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    Recall: Z-0781-05 · Initiated February 25, 2005

    Recall

    Recall Number
    Z-0781-05
    Event Number
    31251
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LLD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 25, 2005
    Posted
    April 28, 2005
    Terminated
    August 9, 2006
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    Reason

    Potential separation of the port base from the port cover after implantation.

    Action

    Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.

    Distribution

    1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control

    Quantity

    214 units