Halyard 45735Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651457353), received between Nov 12, 2018 and Nov 12, 2018 — classified as 1 malfunction.

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

• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT FARRELL ADAPTER PIECES WERE FOUND WHILE MANUALLY VENTING PATIENT. ADDITIONAL INFORMATION RECEIVED ON 29-OCT-2018 STATED THAT ASIDE FROM USING THE FARRELL BAG, THE STOMACH IS VENTED MANUALLY WITH A 60 ML SYRINGE. DURING VENTING, THE PATIENT'S FATHER FOUND 3 SMALL PIECES OF ORANGE PLASTIC IN THE SYRINGE. THE BAG WAS DISCARDED AND THE FATHER DID NOT ACTUALLY SEE A BROKEN ADAPTER OR THAT PIECES WERE MISSING FROM THE ADAPTER. THERE WAS NO PATIENT INJURY NOR INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8062001 ↗