RENASYS EDGE 66803140Recalls & reported problems
Smith & Nephew Medical Limited · 800ml EDGE Canister with Solidifier · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K223041); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 11, 2024Open, Classified
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Z-1597-2024 · Root cause: Under Investigation by firm · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K223041. One submission often covers many models, so check the product and lot details in each record.
- Z-0516-2025 · Oct 2, 2024 · Open, ClassifiedRENASYS 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 irrigat
- Z-1596-2024 · Mar 11, 2024 · Open, ClassifiedRENASYS 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
Other Negative Pressure Wound Therapy Powered Suction Pump devices
- ACTIV.A.C. ™ iOn PROGRESS™ RTMGSM01/USKci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump11 deaths472 reports
- RENASYS GO v2 HOME 66801496Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump424 reports
- RENASYS GO 66021496Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump278 reports
- RENASYS TOUCH 66801280Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump108 reports
- RENASYS EDGE 66803126Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump1 recall28 reports
- PREVENA RESTOR™ BELLA•FORM™ PRE5355Kci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall1 report
- Prevena Plus™ PRE4000USKci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall1 report
- PREVENA RESTOR™ BELLA•FORM™ PRE5255Kci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page