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  • FDA: 778 NPWT Pumps Recalled by Medela
  • 23/07/2018


    Date Initiated by Firm February 07, 2018
    Create Date July 23, 2018
    Recall Status Open, Classified
    Recall Number Z-2528-2018
    Recall Event ID 80078
    510(K)Number K161128
    Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
    Product Invia Motion Negative Pressure Wound Therapy System. Labeled as:
    a. Endure Negative Pressure Wound Therapy (Model 087.4010);
    b. 15 Days Negative Pressure Wound Therapy (Model 087.4012);
    c. 60 Days Negative Pressure Wound Therapy (Model 087.4014)
    Product Usage:
    The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
    Code Information a. Endure Negative Pressure Wound Therapy (Expected life 3 years);  
    b. 15 Days Negative Pressure Wound Therapy (Expected life 15 days);  
    c. 60 Days Negative Pressure Wound Therapy (Expected life 60 days);   
    Serial No. 1670458 1670488; 1670490; 1670492; 1670496 1670512; 1675368 1675419; 1675421 1675431; 1675433 1675443; 1675449; 1676316 1676365; 1676662 1676709; 1676711; 1676713; 1676715; 1676718 - 1676753; 1676755 1676756; 1676758 1676759; 1676762 1676861; 1677718 1677767; 1679752 1679765; 1679767 1679851; 1689658 1689757; 1696087 1696088; 1696095 1696111; 1696113 1696136; 1696356 1696455; 1697916 1697965
    Recalling Firm/
    Medela Inc
    Manufacturer Reason
    for Recall
    Device may display a battery missing error.
    FDA Determined
    Device Design
    Action Medela sent an Notification letter dated February 1, 2018 to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Instructions included to place all affected items on hold until an insert outlining additional charging instructions were included with the devices. Those instructions included to provide a printed copy of the charging instructions in each device package, review those insert instructions with patients and care-givers, and complete and return the confirmation letter.
    Quantity in Commerce 778 units
    Distribution US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX.
    Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands.

    1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
    2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
    3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

    Last Updated: Sept. 12th, 2018

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