Halyard 96897Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30609038093094), received between Jan 16, 2019 and Feb 1, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Component Misassembled” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2019-00012 FOR THE FIRST EVENT. IT WAS REPORTED THAT THE PATIENT WAS INJURED DURING SUCTIONING. THE PATIENT DEVELOPED LESIONS AND HEAVY BLEEDING RUPTURES WHICH REQUIRED AN EAR NOSE & THROAT SPECIALIST TO "OBLITERATE THE WOUNDS."NO FURTHER INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8296112 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2019-00015 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE PATIENT WAS INJURED DURING SUCTIONING. THE PATIENT DEVELOPED LESIONS AND HEAVY BLEEDING RUPTURES WHICH REQUIRED AN EAR NOSE & THROAT SPECIALIST TO "OBLITERATE THE WOUNDS." NO FURTHER INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8296108 ↗
• InjuryJan 16, 2019Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOAM ON THE SUCTION SWABS CHANGED POSITIONING ON THE PLASTIC, WHICH RESULTS IN STRONGER SUCTION INTO THE PATIENT'S MUCOSAL ORAL CAVITIES. THIS HAS LED TO LESIONS WHICH WERE SERIOUS AND REQUIRED MEDICAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED 15 JAN 2019, THE PATIENT HAD "HEAVILY BLEEDING RUPTURES", AND "AN EAR / NOSE / THROAT SPECIALIST HAD TO OBLITERATE THE WOUNDS."

  Patient problems: Erosion

  MAUDE report 8253471 ↗