AVANOS 94865Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770948652), received between Jun 19, 2020 and Jun 19, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2020-00104 FOR THE SECOND REPORT. REFER TO 9611594-2020-00105 FOR THE THIRD REPORT. REFER TO 9611594-2020-00106 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE PORT PLUG PORTION OF THE GASTRIC PORT COVER BROKE OFF AND CLOGGED THE TUBE. THE TUBE WAS FLUSHED WITHOUT THE REALIZATION THAT THE PLUG PORTION WAS INSIDE THE TUBE, AND THE PLUG WAS PUSHED INTO THE PATIENT'S STOMACH. NO PATIENT INJURY WAS REPORT. PHOTOS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10175262 ↗
• MalfunctionJun 19, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2020-00103 FOR THE FIRST REPORT. REFER TO 9611594-2020-00104 FOR THE SECOND REPORT. REFER TO 9611594-2020-00105 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE PORT PLUG PORTION OF THE GASTRIC PORT COVER BROKE OFF AND CLOGGED THE TUBE. THE PATIENT'S MOTHER STATED THAT SHE WAS "ABLE TO SEE IT BEFORE" FLUSHING THE TUBE. NO PATIENT INJURY WAS REPORTED. DATE OF THIS EVENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174801 ↗
• MalfunctionJun 19, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2020-00103 FOR THE FIRST REPORT. REFER TO 9611594-2020-00105 FOR THE THIRD REPORT. REFER TO 9611594-2020-00106 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE PORT PLUG PORTION OF THE GASTRIC PORT COVER BROKE OFF AND CLOGGED THE TUBE. THE PATIENT'S MOTHER STATED THAT SHE WAS "ABLE TO SEE IT BEFORE" FLUSHING THE TUBE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174797 ↗
• MalfunctionJun 19, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2020-00103 FOR THE FIRST REPORT. REFER TO 9611594-2020-00104 FOR THE SECOND REPORT. REFER TO 9611594-2020-00106 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE PORT PLUG PORTION OF THE GASTRIC PORT COVER BROKE OFF AND CLOGGED THE TUBE. THE PATIENT'S MOTHER STATED THAT SHE WAS "ABLE TO SEE IT BEFORE" FLUSHING THE TUBE. NO PATIENT INJURY WAS REPORTED. DATE OF THIS EVENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174795 ↗