RENASYS F LARGE W/SOFT PORT 66020796Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00040565127187), received between May 14, 2021 and Sep 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2021Device Emits Odor; Adverse Event Without Identified Device or Use Problem; Device Emits Odor; Adverse Event Without Identified Device or Use Problem

  IT AS REPORTED THAT DURING THERAPY USING A RENASYS F DEVICE PATIENT STATED THAT ODOR WAS COMING FROM HIS WOUND, THE NURSE CAME OUT THREE TIME A WEEK BUT THE SMELL IS REPULSIVE EVEN THOUGHT SHE CHANGED THE DRESSING. WOUND IS TO THE CHEST AND FROM A BIOPSY THAT BECAME INFECTED. IT IS UNCERTAIN IF THIS ODOR WAS CAUSED BY THE RENASYS, THE DRESSING OR THE SIZE. PATIENT'S STATUS IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Disorders; Unspecified Infection

  MAUDE report 12442622 ↗
• InjuryMay 14, 2021False Alarm; Defective Alarm; Leak/Splash; False Alarm; Defective Alarm; Leak/Splash

  IT WAS REPORTED THAT DURING NPWT WITH RENASYS GO IN A SACRAL WOUND PATIENT A FALSE BLOCKAGE ALARM ACTIVATES. LATER HAD A LEAK AND THE DEVICE DID NO ACTIVATE THE CORRESPONDING ALARM. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED. THE TREATMENT FINISHED WITH A COMPETITOR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829121 ↗

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