BEUDAMED
    FDA Recall Open, Classified

    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

    Recall: Z-1082-2022 · Initiated March 3, 2022

    Recall

    Recall Number
    Z-1082-2022
    Event Number
    89931
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FDT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 3, 2022
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

    Reason

    Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

    Action

    Boston Scientific notified US and US Territories from March 3rd through March 17th, via hand delivery, FedEx, or e-mail . OUS Consignees were notified from March 3rd through March 10th, via hand delivery, courier, or e-mail. Additional US Consignees located in the US and US Territories were notified from April 7, 2022, through April 13, 2022. Additional OUS Consignees were notified on April 7, 2022. Immediate Action Required EXALT Model D Single-Use Duodenoscope. Letter states. Customers to whom hand-delivery is not possible within a ten-day timeframe will receive the letter through other means (e.g., courier, e-mail). The notification instructs the account to review the content of the IFU updates, share the information and post it in a visible location near the product, and to complete the Acknowledgment Form to confirm receipt of the notification. After all applicable regulatory approvals are obtained, the updated IFUs will be packaged with EXALT Model D Single-Use Duodenoscopes. An updated IFU will be available at https://www.bostonscientific.com/elabeling in the US. ***UPDATE 4/29/22: BSC implemented the updated IFU for US customers (an electronic-only IFU published to BSC's website) on March 21 , 2022. This electronic-only IFU supports UPNs M00542420 and M00542421 (the UPNs intended primarily for US distribution). BSC will implement the updated IFU for OUS customers (in UPNs M0054242CE0 and M0054242CE1 , the UPNs intended primarily for OUS distribution) following language translations and receipt of paper IFU inventory, estimated for May 2022.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir.

    Quantity

    OUS: 538 units