Home › Device types › OMP
Negative Pressure Wound Therapy Powered Suction Pump
FDA product code OMP · Class 2 · General, Plastic Surgery
916
Registered devices
9,164
Adverse events
47
Recalls
214
510(k) clearances
Devices with this code
V.A.C.® GRANUFOAM™ Silver™ — KCI USA, INC.CARDINAL HEALTH — Cardinal Health 200, LLCVcare Alpha — I.V.T. MEDICAL LTDHybrid Dressing - Revo Unsterile — GENADYNE BIOTECHNOLOGIES INC.3M™ V.A.C.® Granufoam™ — KCI USA, INC.Invia-Silverlon — ARGENTUM MEDICAL, LLCPREVENA RESTOR™ ARTHRO•FORM™ — KCI USA, INC.PREVENA PLUS™ — KCI USA, INC.Avance — TALLEY GROUP LIMITEDWoundPro Control Unit — Pensar Medical, LLCNEXA Drape — NEXA MEDICAL LIMITEDTzoar — LIGHTSTONE MEDICAL LLCAvance® Solo — Mölnlycke Health Care ABDeRoyal — DEROYAL INDUSTRIES, INC.Advanced Series Combo Pack, Medium — Pensar Medical, LLCRENASYS GO — SMITH & NEPHEW MEDICAL LIMITEDExtriCARE — ALLEVA MEDICAL LIMITEDMicroDoc NPWT System — Pensar Medical, LLCNA — CARILEX MEDICAL, INC.XLR8 Canister — GENADYNE BIOTECHNOLOGIES INC.Foam Medium — GENADYNE BIOTECHNOLOGIES INC.Nisus ONE NPWT System — CORK MEDICAL, LLCRENASYS EDGE — SMITH & NEPHEW MEDICAL LIMITEDPICO — SMITH & NEPHEW MEDICAL LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | KCI USA, INC. | Due to increase in complaints related to leak alarms |
| 2024-11-05 | KCI USA, INC. | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
| 2024-10-02 | Smith & Nephew Medical, Ltd. | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2020-06-08 | KCI USA, INC. | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2019-12-02 | Medela Inc | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
| 2018-02-07 | Medela Inc | Device may display a battery missing error. |
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