Home › Device types › OMP
Negative Pressure Wound Therapy Powered Suction Pump
FDA product code OMP · Class 2 · General, Plastic Surgery
935
Registered devices
9,186
Adverse events
47
Recalls
216
510(k) clearances
Devices with this code
V.A.C.® GRANUFOAM™ — KCI USA, INC.Avance® Solo — Mölnlycke Health Care ABV.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRESSING — KCI USA, INC.Avance® Solo — Mölnlycke Health Care ABCARDINAL HEALTH — Cardinal Health 200, LLCRENaSYS G LaRGE W/SOFT PORT — SMITH & NEPHEW MEDICAL LIMITEDNisus NPWT System — CORK MEDICAL, LLCPICO — SMITH & NEPHEW MEDICAL LIMITEDWoundPro 300cc Basic Canister w/8' Tubing — Pensar Medical, LLCEndo-SPONGE Pump — Meditop B.V.ExtriCARE — ALLEVA MEDICAL LIMITEDUNO Plus Negative Pressure Wound Therapy Device — GENADYNE BIOTECHNOLOGIES INC.Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLCRenasys — SMITH & NEPHEW MEDICAL LIMITEDAvance — Mölnlycke Health Care ABPICO — SMITH & NEPHEW MEDICAL LIMITEDCARDINAL HEALTH — Cardinal Health 200, LLCV.A.C.® — KCI USA, INC.Tzoar — LIGHTSTONE MEDICAL LLCINFOV.A.C.™ — KCI USA, INC.PICO — SMITH & NEPHEW MEDICAL LIMITEDExtriCARE — ALLEVA MEDICAL LIMITEDDeRoyal — DEROYAL INDUSTRIES, INC.UNO 15 Therapy Kit 15x20 — GENADYNE BIOTECHNOLOGIES INC.
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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