AVANOS 40-7438Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00350770460345), received between Jun 3, 2020 and Jul 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042725 ↗
• MalfunctionMay 6, 2026Break; Physical Resistance/Sticking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00281 FOR THE FIRST REPORT. WHEN A SECOND TUBE WAS PLACED, THE SAME ISSUE OCCURRED. RESISTANCE WAS FELT AND IT WAS IMPOSSIBLE TO REMOVE THE GUIDEWIRE. AFTER FORCING, IT DID COME OUT BUT IT BROKE THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093450 ↗
• MalfunctionMay 6, 2026Break; Physical Resistance/Sticking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO FOR THE FIRST REPORT. REFER TO 9611594-2026-00282 FOR THE SECOND REPORT . IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS PLACED WITHOUT DIFFICULTY. WHEN THE GUIDEWIRE WAS BEING REMOVED, RESISTANCE WAS FELT AND IT WAS IMPOSSIBLE TO REMOVE. AFTER FORCING, IT DID COME OUT BUT IT BROKE THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093448 ↗
• MalfunctionMay 5, 2026Material Puncture/Hole; Difficult to Remove

  IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS INSERTED CORRECTLY AND ITS POSITION CHECKED. WHEN IT CAME TO RETRACTING THE GUIDE, IT SEEMED TO BE STUCK. THE GUIDE WAS FINALLY REMOVED, BUT THIS DAMAGED THE PART OF THE PROBE ON THE OUTSIDE OF THE PATIENT'S BODY: A HOLE HAD FORMED. AFTER CHECKING, THE TUBE WAS STILL IN PLACE, AND A BANDAGE WAS APPLIED TO CLOSE THE HOLE AND THE TUBE WAS TESTED WITH WATER. THE TUBE WAS KEPT IN PLACE. IT WAS NOT FLUSHED PRIOR TO REMOVAL OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081183 ↗
• MalfunctionMar 30, 2026Break

  THE CUSTOMER REPORTED ¿A PIECE OF THE GUIDEWIRE BROKE OFF AND REMAINED IN THE DHT (DOBBHOFF TUBE).¿ PER ADDITIONAL INFORMATION RECEIVED ON 02-MAR-2026, ISSUES WITH ADMINISTERING MEDICATIONS AND TUBE FEEDING WERE NOTED BEGINNING ON (B)(6) 2026. REPEAT X-RAYS WERE PERFORMED AND THE ISSUE WAS ESCALATED TO THE MEDICAL INTENSIVE CARE UNIT (MICU) TEAM. AFTER MORE THAN 24 HOURS OF MEDICATION ADMINISTRATION ISSUES, THE DECISION WAS MADE TO REPLACE THE DHT WITH A NASOGASTRIC TUBE (NGT). UPON REMOVAL OF THE DHT, THE DISTAL END OF THE TUBE WAS NOTED TO BE INFLEXIBLE AND CONTAINED A RETAINED PIECE OF THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736639 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED "A LARGE PIECE OF A DOBHOFF TUBE WAS INCIDENTALLY FOUND INSIDE [THE PATIENT'S] STOMACH AND RETRIEVED. IT IS UNCLEAR IF THIS OCCURRED OVER TIME IF IT CAN DEGRADE, WEAKEN, OR BECOME BRITTLE DUE TO THE GASTRIC ENVIRONMENT RESULTING IN AN EQUIPMENT MALFUNCTION." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21412880 ↗
• MalfunctionMay 25, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  FDA USER FACILITY REPORT MW REPORT (B)(4) RECEIVED REPORTED, PATIENT HAD BEEN HAVING WHITE MUCOUS BALLS IN STOOL AND RETCHING OVERNIGHT. TEAM DECIDED TO REMOVE NDT (NASODUODENAL (ND) FEEDING TUBE) TO REPLACE. NDT HAD BEEN IN PLACE APPROXIMATELY 2 MONTHS. UPON REMOVING TUBE, END OF TUBE WAS NOT INTACT, LOOKED LIKE THE TUBE DISINTEGRATED AND ABOUT 1CM OF TUBE WAS MISSING. KUB (KIDNEY, URETER, AND BLADDER X-RAY) WAS OBTAINED, AND PART OF THE WEIGHTED TIP WAS VISIBLE. (CORFLO NASOGASTRIC FEEDING TUBE 8FR 109CM). NO PATIENT HARM, BOWEL MOVEMENT INCLUDED PASSING OF RETAINED NG TUBE PIECE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17006010 ↗
• MalfunctionFeb 22, 2021Migration or Expulsion of Device; Material Split, Cut or Torn; Migration or Expulsion of Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT "THE PROBE [NG TUBE] WAS LAID ON (B)(6) 2020 WITH A RADIO CONTROL WHICH CONFIRMED THE CORRECT INSTALLATION. ON (B)(6) 2021 THE PATIENT COUGHED A LOT AND THE PROBE ENDED UP IN HIS MOUTH. THE NURSE OBSERVED A HERNIA AND THE BALLOON WITH A TEAR ON THE SIDE." A NEW NG TUBE WAS PLACED. NO PATIENT INJURY WAS NOTED AND NO MEDICAL TREATMENT WAS REQUIRED. CURRENT STATUS OF THE PATIENT IS "OK." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Cough

  MAUDE report 11362519 ↗
• MalfunctionSep 10, 2020Material Perforation; Material Perforation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2020-00174 FOR THE FIRST REPORT. REFER TO 9611594-2020-00176 FOR THE THIRD REPORT. IT WAS REPORTED THAT DURING PLACEMENT, THE DOCTOR HAD DIFFICULTY REMOVING THE STYLET FROM THE NASOGASTRIC (NG) TUBE. UPON REMOVAL, THE NG TUBE HAD HOLES IN IT. PER ADDITIONAL INFORMATION RECEIVED 02 SEP 2020, ATTEMPTING REMOVAL OF THE STYLETS RESULTED IN DETERIORATION OF THE NG TUBE, AND LED TO HOLES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10514298 ↗
• MalfunctionSep 10, 2020Material Perforation; Material Perforation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2020-00174 FOR THE FIRST REPORT. REFER TO 9611594-2020-00175 FOR THE SECOND REPORT. IT WAS REPORTED THAT DURING PLACEMENT, THE DOCTOR HAD DIFFICULTY REMOVING THE STYLET FROM THE NASOGASTRIC (NG) TUBE. UPON REMOVAL, THE NG TUBE HAD HOLES IN IT. PER ADDITIONAL INFORMATION RECEIVED ON 02 SEP 2020, ATTEMPTING REMOVAL OF THE STYLETS RESULTED IN DETERIORATION OF THE NG TUBE, AND LED TO HOLES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10514046 ↗
• MalfunctionSep 10, 2020Material Perforation; Material Perforation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2020-00175 FOR THE SECOND REPORT. REFER TO 9611594-2020-00176 FOR THE THIRD REPORT. IT WAS REPORTED THAT DURING PLACEMENT, THE DOCTOR HAD DIFFICULTY REMOVING THE STYLET FROM THE NASOGASTRIC (NG) TUBE. UPON REMOVAL, THE NG TUBE HAD HOLES IN IT. PER ADDITIONAL INFORMATION RECEIVED 02 SEP 2020, ATTEMPTING REMOVAL OF THE STYLETS RESULTED IN DETERIORATION OF THE NG TUBE, AND LED TO HOLES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10514043 ↗
• MalfunctionJun 3, 2020Burst Container or Vessel; Material Separation; Obstruction of Flow; Burst Container or Vessel; Material Separation; Obstruction of Flow

  IT WAS REPORTED THAT "THE PROBE HAD BEEN IN PLACE FOR A FEW DAYS. IT WAS CLOGGED. RADIO CONTROL WAS REQUIRED. THE PROBE WAS CUT 55 CM FROM THE DISTAL TIP AND THEREFORE A PIECE OF THE PROBE REMAINED IN THE STOMACH. FIBROSCOPY FOR REMOVAL OF THE PIECE OF PROBE LEFT IN THE STOMACH. NO PATIENT CONSEQUENCES. ACCORDING TO PRELIMINARY INFORMATION, THE PROBE WAS NOT CUT BY A SCALPEL, THERE WOULD HAVE BEEN LIKE A PLUG WHICH WOULD HAVE SWELLED LIKE A BALLOON AND BURST." "BREAK DUE TO BEING CLOGGED AND THERE BEING PRESSURE." ADDITIONAL INFORMATION RECEIVED 19-MAY-2020 INCLUDED IMAGES OF THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10116663 ↗