Halyard 94927Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651949278), received between Mar 22, 2017 and Mar 22, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00049 FOR THE SECOND REPORT. IT WAS REPORTED BY A CAREGIVER THAT, A PATIENT CHOKED ON THE GASTRIC PORT STRAP OF THE EXTENSION SET. THE PATIENT BIT INTO AND BROKE OFF THE GASTRIC PORT STRAP ON THE EXTENSION SET, WHICH RESULTED IN THE PATIENT CHOKING ON THE STRAP. THE CAREGIVER IS AN EMERGENCY MEDICAL TECHNICIAN AND PERFORMED BACK THRUSTS SEVERAL TIMES, WITH FINGER SWEEPS TO REMOVE THE STRAP FROM THE PATIENT¿S THROAT. THE ENTIRE PORTION WAS RETRIEVED AND THE PATIENT IS DOING WELL. THE CAREGIVER STATED, THE PATIENT HAS NO ORAL INTAKE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6425232 ↗
• MalfunctionMar 22, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00048 FOR THE FIRST REPORT. IT WAS REPORTED BY A CAREGIVER THAT, A PATIENT CHOKED ON THE GASTRIC PORT STRAP OF THE EXTENSION SET. THE PATIENT BIT INTO AND BROKE OFF THE GASTRIC PORT STRAP ON THE EXTENSION SET, WHICH RESULTED IN THE PATIENT CHOKING ON THE STRAP. THE CAREGIVER IS AN EMERGENCY MEDICAL TECHNICIAN AND PERFORMED BACK THRUSTS SEVERAL TIMES, WITH FINGER SWEEPS TO REMOVE THE STRAP FROM THE PATIENT¿S THROAT. THE ENTIRE PORTION WAS RETRIEVED AND THE PATIENT IS DOING WELL. THE CAREGIVER STATED, THE PATIENT HAS NO ORAL INTAKE. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6424790 ↗