BEUDAMED
    FDA Recall Terminated

    Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182480 18-248 RENEGADE 105/3.0/2.5/.021/20/STRAIGHT M001182510 18-251 F/G RENEGADE 150/10/1TIP M001182520 18-252 F/G RENEGADE 130/20/1TIP M001182530 18-253 F/G RENEGADE 150/20/1TIP

    Recall: Z-2246-2009 · Initiated August 26, 2009

    Recall

    Recall Number
    Z-2246-2009
    Event Number
    53143
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 26, 2009
    Posted
    September 24, 2009
    Terminated
    August 24, 2012
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, Renegade Fiber Braided Microcatheter, Peripheral Vascular Use, RX Only, Sterilized using ethylene oxide, Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. Material Catalog # Description M001182480 18-248 RENEGADE 105/3.0/2.5/.021/20/STRAIGHT M001182510 18-251 F/G RENEGADE 150/10/1TIP M001182520 18-252 F/G RENEGADE 130/20/1TIP M001182530 18-253 F/G RENEGADE 150/20/1TIP

    Reason

    Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached.

    Action

    Consignees were sent a Boston Scientific Urgent Medical Device Recall Removal - Immediate Action Required letter Dated August 26,2009. The letter was addressed to Risk Manager / Field Action Contact. The letter described the problem and product involved. Advised consignees to segregate the affected product and return it to Boston Scientific. Requested the return and completion of The Account Reply Verification Tracking form enclosed. Replacements will be issued for all recalled product that is properly returned to Boston Scientific.

    Distribution

    Worldwide Distribution -- USA, excluding New Mexico and Wyoming, and countries of Europe, the Middle East and Africa, Japan, American Virgin Islands, Argentina, Aruba, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dutch Antilles, Egypt, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Libya, Luxembourg, Macau, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Romania, Saudia Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, and Vietnam.

    Quantity

    28,947 (11,050 US; 17,897 OUS)