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Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressur...

FDA Device Recall #Z-2528-2018 — Class II — February 7, 2018

Recall Summary

Recall Number Z-2528-2018
Classification Class II — Moderate risk
Date Initiated February 7, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medela Inc
Location McHenry, IL
Product Type Devices
Quantity 778 units

Product Description

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.

Reason for Recall

Device may display a battery missing error.

Distribution Pattern

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.

Lot / 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;

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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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