RENASYS F MEDIUM W/SOFT PORT 66020795Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00040565127170), received between May 18, 2021 and May 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Alarm” (1 report).

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.

• MalfunctionMay 18, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING NPWT, THE RENASYS DEVICE DISPLAYED A BLOCKAGE ALARM AFTER APLICATION OF THE DRESSING. THE DRAINAGE WAS INSPECTED AND NO ACTUAL BLOCKAGE WAS FOUND IN THE TUBING. THE DRESSING WAS CHANGED BUT THE ALARM CONTINUED. THE TREATMENT WAS RESUMED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844905 ↗

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