RENASYS EDGE 66803139Recalls & reported problems

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

1. 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-1596-2024 · 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, Classified
  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 irrigat
• Z-1597-2024 · Mar 11, 2024 · Open, Classified
  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