Negative Pressure Wound Therapy Powered Suction Pump
Kci Usa, Inc.'s record for this product code
Recent MDR events
1,041 adverse event reports on file
- PREVENA PLUS¿Jun 8, 2026Malfunction25427104
- PREVENA¿ PEEL PLACE¿May 27, 2026Malfunction25299744
- PREVENA¿ PEEL PLACE¿May 5, 2026Malfunction25080978
- PREVENA PLUS¿Apr 24, 2026Malfunction24980050
- PREVENA¿ PEEL PLACE¿Jan 29, 2026Malfunction24214611
- PREVENA PLUS 125Jan 22, 2026Malfunction24144183
- ABTHERAJan 15, 2026Injury24078669
- PREVENA¿ PEEL PLACE¿Dec 16, 2025Malfunction23815559
- PREVENA PLUS¿Nov 19, 2025Malfunction23592485
- ACTIV.A.C.Oct 27, 2025InjuryMW5177949
Recalls
17 recall events for this product code
- Open, ClassifiedFeb 14, 2025
Due to increase in complaints related to leak alarms
View FDA record ↗ - Open, ClassifiedNov 22, 2024
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
View FDA record ↗ - TerminatedJan 6, 2016
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
View FDA record ↗ - TerminatedOct 15, 2014
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗ - TerminatedMar 5, 2014
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
View FDA record ↗
510(k) clearances
39 clearances for this product code
- K241134May 23, 2024
3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K201571Jul 8, 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
- K200390May 18, 2020
V.A.C. DERMATAC Drape
- K190697Nov 22, 2019
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
- K181505Mar 28, 2019
V.A.C. DERMATAC Drape
- K183543Mar 20, 2019
ACTIV.A.C. Therapy Unit
- K181507Feb 15, 2019
PREVENA RESTOR(TM) Incision Management System
- K180855Jun 1, 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
- K173426Mar 9, 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
- K173447Mar 2, 2018
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit