BEUDAMED
    FDA Recall Terminated

    Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.

    Recall: Z-2765-2015 · Initiated August 25, 2015

    Recall

    Recall Number
    Z-2765-2015
    Event Number
    72045
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    NGV
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    August 25, 2015
    Terminated
    April 4, 2017
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.

    Reason

    Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.

    Action

    Consignees were sent a Boston Scientific "Urgent Field Correction" letter dated August 25, 2015. The letter was addressed to Materials manager / Field Action Contact. The letter described the problem and the product affected. The Field Correction reinforces existing Directions for USE (DFU) and provides further guidance regarding the correct us of the hemostatis valve in order to avoid cross-threading and to securely seal the valve, minimizing the poential for undesirable blood leakage. The consignees were informed of the action required which stated that no product is required to be returned and advised to consignees that they must complete the Customer Acknowledgement Form and return it to Boston Scientific (MapleGroveFieldAction [email protected] or Fax to Field action Center 1-866-213-1806). The letter also provided a section of the Updated Directions for Use which were highlighted in blue. If the consignee is a distributor the Field Correction is to the hospital level. For questions, customers may contact their Local Sales Representative.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.

    Quantity

    29,169 units total