FDA Device recall Z-2528-2018
Invia Motion Negative Pressure Wound Therapy System
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Invia Motion Negative Pressure Wound Therapy System by Medela, citing device may display a battery missing error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2528-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-07 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medela |
| Distribution | US |
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.
Reason
Device may display a battery missing error.
Identifiers
| code_info | a. Endure Negative Pressure Wound Therapy (Expected life 3 years); b. 15 Days Negative Pressure Wound Therapy (Expec…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; 16609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2528-2018%22
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