Renasys 66020799Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00040565127248), received between Oct 2, 2023 and Oct 2, 2023 — classified as 1 injury.

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 16, 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.

• InjuryOct 2, 2023False Alarm; Obstruction of Flow; False Alarm; Obstruction of Flow

  IT WAS REPORTED THAT, DURING NPWT A RENASYS GO CONTINUES TO ALARM BLOCKAGE/FULL CANISTER, SPECIFICALLY ON SUNDAYS. THE WOUNDS ARE FILLED WITH GAUZE. PATIENT HAS DRESSING CHANGES AND WHEN SHE GOES TO HE PROVIDERS OFFICE ON FRIDAYS THE GAUZE WHICH IS PACKING THE WOUND IS FILLED WITH DRAINAGE AND THE WOUND CONTINUES TO NEED DEBRIDED, PATIENT STATES THAT THEY CAN SEE THE EDGES OF THE WOUND ARE WHIT AGAIN AND THE WOUND IS NOT HEALING. PATIENT IS CONCERNED THAT THE POOLING IS PREVENTING HEALING IN ADDITION TO THE BLOCKAGE ALARMS.. IT IS UNKNOWN HOW THE THERAPY WAS FINISHED; HOWEVER, NO DELAYS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Impaired Healing

  MAUDE report 17857916 ↗

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