Negative Pressure Wound Therapy Powered Suction Pump

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-02-14Open, ClassifiedDevice Design

  3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper

  Due to increase in complaints related to leak alarms

• 2024-11-22Open, ClassifiedUse error

  V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

  Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

• 2024-11-22Open, ClassifiedProcess control

  RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

  Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

• 2024-04-18Open, ClassifiedUnder Investigation by firm

  RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139

  Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

• 2024-04-18Open, ClassifiedUnder Investigation by firm

  RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140

  Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

• 2018-07-23TerminatedDevice Design

  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.

  Device may display a battery missing error.

• 2016-01-06TerminatedPackage design/selection

  ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.

  There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

• 2014-10-15TerminatedError in labeling

  V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.

  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.

• 2014-10-08TerminatedDevice Design

  RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

  RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

• 2014-10-08TerminatedDevice Design

  RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

  RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.