AVANOS 42-7558Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770460833), received between Mar 26, 2025 and Nov 7, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 9611594-2025-00263 FOR THE FIRST EVENT. REFER TO 9611594-2025-00264 FOR THE SECOND EVENT. REFER TO 9611594-2025-00265 FOR THE THIRD EVENT. REFER TO 9611594-2025-00267 FOR THE FIFTH EVENT. IT WAS REPORTED THE NASOJEJEUNAL (NJ) TUBE WAS GUIDEWIRE WAS NOTICED TO BE INTERMITTENTLY PROTRUDING WHEN THE TUBE WAS INSIDE THE PATIENT. UNKNOWN IF INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED 22-OCT-2025 STATED "ON FLUSHING TUBE PRIOR TO INSERTION THE GUIDE WIRE PROTRUDED OUTSIDE OF THE SIDE FEEDING HOLE BY 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503619 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 9611594-2025-00263 FOR THE FIRST EVENT. REFER TO 9611594-2025-00264 FOR THE SECOND EVENT. REFER TO 9611594-2025-00266 FOR THE FOURTH EVENT. REFER TO 9611594-2025-00267 FOR THE FIFTH EVENT. IT WAS REPORTED THE NASOJEJEUNAL (NJ) TUBE WAS GUIDEWIRE WAS NOTICED TO BE INTERMITTENTLY PROTRUDING WHEN THE TUBE WAS INSIDE THE PATIENT. UNKNOWN IF INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED 22-OCT-2025 STATED "ON FLUSHING TUBE PRIOR TO INSERTION THE GUIDE WIRE PROTRUDED OUTSIDE OF THE SIDE FEEDING HOLE BY 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503617 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 9611594-2025-00263 FOR THE FIRST EVENT. REFER TO 9611594-2025-00264 FOR THE SECOND EVENT. REFER TO 9611594-2025-00265 FOR THE THIRD EVENT. REFER TO 9611594-2025-00266 FOR THE FOURTH EVENT. IT WAS REPORTED THE NASOJEJEUNAL (NJ) TUBE WAS GUIDEWIRE WAS NOTICED TO BE INTERMITTENTLY PROTRUDING WHEN THE TUBE WAS INSIDE THE PATIENT. UNKNOWN IF INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED 22-OCT-2025 STATED "ON FLUSHING TUBE PRIOR TO INSERTION THE GUIDE WIRE PROTRUDED OUTSIDE OF THE SIDE FEEDING HOLE BY 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503615 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 9611594-2025-00263 FOR THE FIRST EVENT. REFER TO 9611594-2025-00265 FOR THE THIRD EVENT. REFER TO 9611594-2025-00266 FOR THE FOURTH EVENT. REFER TO 9611594-2025-00267 FOR THE FIFTH EVENT. IT WAS REPORTED THE NASOJEJEUNAL (NJ) TUBE WAS GUIDEWIRE WAS NOTICED TO BE INTERMITTENTLY PROTRUDING WHEN THE TUBE WAS INSIDE THE PATIENT. UNKNOWN IF INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED 22-OCT-2025 STATED "ON FLUSHING TUBE PRIOR TO INSERTION THE GUIDE WIRE PROTRUDED OUTSIDE OF THE SIDE FEEDING HOLE BY 1-2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503613 ↗
• MalfunctionNov 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 9611594-2025-00264 FOR THE SECOND EVENT. REFER TO 9611594-2025-00265 FOR THE THIRD EVENT. REFER TO 9611594-2025-00266 FOR THE FOURTH EVENT. REFER TO 9611594-2025-00267 FOR THE FIFTH EVENT. IT WAS REPORTED THE NASOJEJEUNAL (NJ) TUBE WAS GUIDEWIRE WAS NOTICED TO BE INTERMITTENTLY PROTRUDING WHEN THE TUBE WAS INSIDE THE PATIENT. UNKNOWN IF INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED 22-OCT-2025B STATED "ON FLUSHING TUBE PRIOR TO INSERTION THE GUIDE WIRE PROTRUDED OUTSIDE OF THE SIDE FEEDING HOLE BY 1-2MM... THERE WAS ONE OCCURRENCE OF THE GUIDE PROTRUDING OUT OF THE SIDE HOLE (BY 1-2MM) WHILST INSIDE A PATIENT. AT THIS POINT THE WIRE WAS REMOVED AND EXCHANGED FOR A HYDROPHILIC GUIDE WIRE TO ENABLE THE INSERTION TO CONTINUE WITHOUT HAVING TO REMOVE THE TUBE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503611 ↗
• MalfunctionMar 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL 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 9611594-2025-00067 FOR THE FIRST EVENT. IT WAS REPORTED THE WIRE WAS PROTRUDING FROM THE DISTAL END OF THE TUBE DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706795 ↗
• MalfunctionMar 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AVANOS MEDICAL 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 9611594-2025-00068 FOR THE SECOND EVENT. IT WAS REPORTED THE WIRE WAS PROTRUDING FROM THE DISTAL END OF THE TUBE." THE WIRE WAS NOT PROTRUDING AT THE TIME OF FLUSHING, PRIOR TO INSERTION. IT BECAME EVIDENT WHEN THE TUBE WAS REMOVED DUE TO ISSUES IN THE PHARYNX." ADDITIONAL INFORMATION RECEIVED 25-MAR-2025 STATING THE "PATIENT FELT DISCOMFORT WHEN TUBE PASSED INTO PHARYNX." THE PATIENT HAD A STRONG GAG REFLEX. THERE WAS NO REPORTED MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701832 ↗