Halyard 13231Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651132318), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flaked” (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 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.

• MalfunctionApr 25, 2023Flaked; Flaked

  SURGICAL DRAPE MATERIAL IS COMING OFF. BITS OF THE MATERIAL HAVE BECOME LOOSE ON THE SURGICAL FIELD AS A RESULT. THE END USER'S HANDS AND ARMS ARE IN CONTACT WITH THE DRAPE. THE SURGEON AND OR STAFF ARE CONCERNED THAT THE DEBRIS MAY COME IN CONTACT WITH THE SURGICAL INCISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16812352 ↗