Class 2 Device Recall Invia Motion Negative Pressure Wound Therapy System.

• Date Initiated by Firm: February 07, 2018
• Date Posted: July 23, 2018
• Recall Status: Terminated on December 04, 2018
• 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); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). 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); d. Endure Negative Pressure Wound Therapy (Expected life 3 years); e. 15 Days Negative Pressure Wound Therapy (Expected life 15 days); f. 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; 160884 885; 1660887; 1660894 895; 1660901 903; 1660907; 1660915; 1660918 919; 1660921 22; 1660929; 1660934 935; 1660937; 1660940; 1660953; 1660955; 1660957 959; 1660961 963; 1660966; 1660969; 1660977 980; 1660986; 1660988; 1660991 998; 16611001 002; 1661005; 1661013 014; 1661018; 1661020; 1661032; 1661042; 1661052; 1661055; 1661062; 1661064; 1661066; 1661069; 1661076; 1661078; 1661081; 1661083; 1661086; 1661090; 1661092; 1661094 096; 1661099 112; 1661115; 1661117; 1661122; 1661123; 1662223; 1662230; 1662233; 1662237; 1662241 243; 1662245; 1662247 248; 1662252; 1662255 260; 1662263; 1662265 266; 1668362 369; 1668380 385; 1668392 394; 1668396 398; 1668402 403; 1668426; 1668430; 1668437; 1668441; 1668447; 1668451 452; 1668454 455; 1668458; 1668463; 1668466; 1668469; 1668473; 1668488; 1668494 495; 1668506 507; 1668512 515; 1668520 529; 1669591 593; 1669595 601; 1670635; 1670638; 1670641 642; 1670683 689; 1670694; 1670696; 1670698 706; 1670997; 1660883 884; 1660886; 1660888 893; 1660895 900; 1660904 906; 1660908 914; 1660916 917; 1660920; 1660923 933; 1660936 952; 1660954; 1660956; 1660960; 1660964 965; 1660967; 1660974 976; 1660981 984; 1660986 987; 1661000; 1661010; 1661021; 1661029; 1661036; 1661040; 1661049; 1661056; 1661060; 1661065; 1661073; 1661080; 1661084 085; 1661087; 1661089; 1661091; 1661093; 1661095; 1661097 098; 1661100 116; 1661118 121; 1661123 124; 1662225; 1662227; 1662232; 1662234; 1662236; 1662238 240; 1662244; 1662249 250; 1662253 254; 1662261 262; 1662264; 1668350; 1668375 376; 1668379; 1668386 387; 1668389 391; 1668395; 1668399 401; 1668405; 1668407 408; 1668410 416; 1668418 419; 1668421 425; 1668427; 1668432 439; 1668443 445; 1668447; 1668449; 1668453; 1668456 457; 1668459 462; 1668467 468; 1668471; 1668474; 1668481; 1668484; 1668492 494; 1668496 497; 1668501 502; 1668509 510; 1668514; 1668516 517; 1668520; 1668522
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; McHenry IL 60050-7006
• For Additional Information Contact: 877-735-1626
• Manufacturer Reason for Recall: Device may display a battery missing error.
• FDA Determined Cause: 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. For questions contact Medela Partner Services at info-healthcare@medela.com or via phone 877-735-1626.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OMP