AVANOS CRKA-17-75-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493478828), received between Sep 23, 2026 and Sep 23, 2026 — classified as 1 injury.

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.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported "the day after the Coolief procedure, the patient experienced pain, warmth, and increased effusion in the left knee, raising suspicion of an infection. Blood was observed in the synovial fluid; however, no accumulation of pus was identified. The procedure was performed using aseptic technique."The patient underwent a bilateral COOLIEF procedure on (b)(6) 2026. The patient developed left knee pain one day after the procedure and right knee pain two days after the procedure.The reported symptoms included pain and warmth in the left knee with a slight increase in the pre-existing knee effusion. Information regarding pain severity, erythema, fever, or other signs of infection was not available.A joint aspiration and synovial fluid examination were performed approximately three days post-procedure. The aspirated fluid reportedly contained calcium pyrophosphate crystals, and the fluid appearance was described as approximately 50% blood-tinged, with no evidence of pus accumulation.Based on the clinical presentation and synovial fluid findings, the treating physician diagnosed the event as a pseudogout attack and indicated that there was no causal relationship to the COOLIE

  Patient problems: Fever; Fluid Discharge; Pain

  MAUDE report 50872977 ↗