RENASYS F SMALL W/SOFT PORT 66020794Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00040565127163), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K142979); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHILE USING AN UNKNOWN RENASYS ON A PRESSURE INJURY (POSSIBLY STAGE 3) LOCATED ON THE PATIENT¿S LEFT ISCHIAL TUBEROSITY. THE PATIENT IS SEEING LITTLE PROGRESS AND FEELS THE WOUND IS ACTUALLY GETTING WORSE. THE WOUND IS APPROXIMATELY 3.5CM DEEP AND NOW A TUNNEL HAS BEEN IDENTIFIED IN IT. ALSO NURSES DO ATTEMPT TO DEBRIDE AND ADVISED THEY USE THE PLUROGEL TO KEEP THE WOUND MOIST. THIS ADVERSE EVENT IS STILL ONGOING, AND IT IS UNKNOWN WHAT ACTIONS WILL BE TAKEN TO SOLVE IT.

  Patient problems: Discomfort; Impaired Healing

  MAUDE report 16304412 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142979. One submission often covers many models, so check the product and lot details in each record.

• Z-2848-2016 · Jul 21, 2016 · Open, Classified
  RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction devi