AVANOS 40-1362Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770459974), received between Jun 8, 2021 and Mar 1, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2022-00022 FOR THE FIRST REPORT. REFER TO 9611594-2022-00023 FOR THE SECOND REPORT . REFER TO 9611594-2022-00025 FOR THE FOURTH REPORT . IT WAS REPORTED A PERFORATION OCCURRED, WITH THE CORFLO BOLUS FEED NG TUBE. THE EVENT OCCURRED WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON 01FEB2022 REPORTED THAT THERE WAS A PERFORATION AND THERE WAS NO MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON 17FEB2022 REPORTED THAT TWO CLINICIANS (A REGISTERED NURSE (RN) OF 5 YEARS/NATIONAL CERTIFIED COUNSELOR (NCC) AND AN ORIENTING RN OF THREE YEARS) MADE A TOTAL OF 10 ATTEMPTS TO INSERT THE TUBE; IT WAS NOTED THAT 30 CM OF THE TUBE WAS COILED AND THAT ONE OF THE ATTEMPTS, TO INSERT THE TUBE, RESULTED IN AN ESOPHAGEAL PERFORATION. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Perforation of Esophagus

  MAUDE report 13634915 ↗
• InjuryMar 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2022-00022 FOR THE FIRST REPORT. REFER TO 9611594-2022-00023 FOR THE SECOND REPORT. REFER TO 9611594-2022-00024 FOR THE THIRD REPORT . IT WAS REPORTED A PERFORATION OCCURRED, WITH THE CORFLO BOLUS FEED NG TUBE. THE EVENT OCCURRED WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED THAT THERE WAS A PERFORATION AND THERE WAS NO MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, IT WAS REPORTED THAT FOUR (4) NURSES, (A REGISTERED NURSE (RN) OF 1 YEAR, AN RN OF 22 YEARS, AN RN OF 10 YEARS AND AN RN OF 44 YEARS), OVER TWO SHIFTS, MADE MULTIPLE ATTEMPTS TO INSERT THE SOFT NG TUBE. AFTERWARDS, THE PNUEMOTHORAX WAS DISCOVERED. THE PATIENTS CURRENT CONDITION IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 13634832 ↗
• InjuryFeb 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2022-00022 FOR THE FIRST REPORT, REFER TO 9611594-2022-00024 FOR THE THIRD REPORT, REFER TO 9611594-2022-00025 FOR THE FOURTH REPORT. IT WAS REPORTED A PERFORATION OCCURRED, WITH THE CORFLO BOLUS FEED NG TUBE. THE EVENT OCCURRED WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED A PERFORATION; THERE WAS NO REPORT OF ANY MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED THAT THE SOFT NG TUBE WAS PREVIOUSLY PLACED BY INTRAVENOUS RADIOLOGY (IR), THE TUBE WAS KINKED AND REPOSITIONING WAS ATTEMPTED. THE TUBE WAS REMOVED AND REPLACED BY A NATIONAL CERTIFIED COUNSELOR (NCC)/ REGISTERED NURSE (RN) WHO MADE TWO ATTEMPTS TO PLACE THE TUBE ONE OF WHICH RESULTED IN A SUBSEQUENT PNUEMOTHORAX. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 13625627 ↗
• InjuryFeb 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2022-00023 FOR THE SECOND REPORT, REFER TO 9611594-2022-00024 FOR THE THIRD REPORT AND REFER TO 9611594-2022-00025 FOR THE FOURTH REPORT. IT WAS REPORTED A PERFORATION OCCURRED, WITH THE CORFLO BOLUS FEED NG TUBE. THE EVENT OCCURRED WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON 01-FEB-2022 REPORTED THAT THERE WAS A PERFORATION AND THERE WAS NO MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 17-FEB-2022, REPORTED THAT THE TRAUMA SURGICAL INTENSIVE CARE UNIT (TSICU) REGISTERED NURSE (RN), OF 9 YEARS MADE A SINGLE ATTEMPT [TO INSERT THE TUBE] THAT RESULTED IN A NASO/OROPHARYNX PERFORATION. THE PATIENT REPORTEDLY WAS ALERT AND ORIENTED AND DENIED ANY PAIN WITH THE PLACEMENT OF THE SOFT NG TUBE. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Perforation of Esophagus

  MAUDE report 13625617 ↗
• InjuryJun 8, 2021Adverse 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 PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00078 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE WAS PLACED, WITHOUT STYLET, WHILE THE PATIENT WAS AWAKE AND COOPERATIVE, AND DID NOT COMPLAINT OF ANY PAIN, SO THAT THE NG TUBE WAS PLACED WITHOUT DIFFICULTY. PLACEMENT CONFIRMED VIA A KIDNEY, URETER, AND BLADDER X-RAY (KUB). THE X-RAY SHOWED AIR IN THE ABDOMEN, BUT THE TUBE WAS SHOWN TO OVERLIE THE GASTRIC BODY. A CT SCAN WAS ORDERED TO ASSESS THE AIR IN THE ABDOMEN, AND SHOWED THAT THE NG TUBE HAD PERFORATED THE NASAL PHARYNX. THE TUBE WAS REMOVED AFTER GIVEN THE OK BY THE CARDIO-THORACIC SURGICAL CONSULT. GASTRO-INTESTINAL DOCTOR CONSULTED FOR PLACEMENT OF NEW TUBE, AND THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS DISCHARGED TO REHAB.

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

  MAUDE report 11960006 ↗
• InjuryJun 8, 2021Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00077 FOR THE FIRST REPORT. IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE WAS PLACED POST-THROMBECTOMY AND WAS REPLACED UPON ARRIVAL TO NEURO CRITICAL CARE DUE TO NON-PATENCY. A KIDNEY, URETER, AND BLADDER X-RAY (KUB) WAS DONE TO CONFIRM PLACEMENT OF THE NEW NG TUBE, WHICH INDICATED LEFT LUNG PLACEMENT WITH POSSIBLE SMALL PNEUMOTHORAX. AN X-RAY PERFORMED LATER INDICATED THAT THE PNEUMOTHORAX HAD WORSENED AND THE LEFT LUNG WAS COLLAPSED. DUE TO WORSENING CO-MORBIDITIES (CEREBRAL EDEMA), THE PATIENT WAS PLACED IN COMFORT CARE AND NO FURTHER INTERVENTION WAS DONE.

  Patient problems: Pneumothorax

  MAUDE report 11960004 ↗