BEUDAMED
    FDA Recall Terminated

    Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.

    Recall: Z-2743-2018 · Initiated November 22, 2017

    Recall

    Recall Number
    Z-2743-2018
    Event Number
    80079
    Firm
    Apollo Endosurgery Inc
    FEI Number
    3006722112
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 22, 2017
    Terminated
    October 6, 2020
    Address
    1120 S Capital Of Texas Hwy, Ste 1 300, West Lake Hills, TX, 78746-6464

    Description

    Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band.

    Reason

    Component of the Lap-Band system was missing from the package

    Action

    Consignees were initially contacted via telephone and later via letter. The firms letter requested the hospital risk manager dispose of the defective product.

    Distribution

    Worldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom

    Quantity

    54