Halyard 42307Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30680651423079), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 malfunction.

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

• MalfunctionAug 26, 2019Material Frayed; Material Frayed

  MEDWATCH FORM MW5087952 WAS RECEIVED ON 06AUG2019 THAT STATES FIBERS WERE NOTICED IN THE PATIENT'S EYES AND THE PATIENT WAS MONITORED FOR INCREASED INCIDENCE OF INFLAMMATION. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09-AUG-2019 THAT STATES, "THIS IS BEING EVALUATED AT THE VA NATIONAL PATIENT SAFETY LEVEL. I CANNOT SHARE INFORMATION ON THESE CASES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930115 ↗