Halyard NCDS019-02_0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10809160319628), received between Jan 20, 2026 and Jan 20, 2026 — classified as 1 injury.

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

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.

• InjuryJan 20, 2026Contamination

  CUSTOMER REPORTED THAT CONTAINER WITHIN ABDOMINAL TRANSPLANT PACK CRACKED DURING ORGAN (KIDNEY) TRANSPORT RENDERING THE ORGAN UNUSABLE. DETAILS ON THE STATUS OF DONOR OR INTENDED RECIPIENT ARE UNKNOWN, THE REPORTER INDICATED THAT THEIR POLICY IS TO NOT SHARE THESE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115887 ↗