AVANOS 40-3551Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770460178), received between Jun 19, 2022 and Jun 2, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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.

• MalfunctionJun 2, 2026Stretched

  THE FOOD AND DRUG ADMINISTRATION MEDSUN REPORT(B)(4) REPORTED ¿NJ "[NASO-JEJUNAL]" TUBE SWELLING NOTED IN IMAGING, LATER RUPTURE OF TUBE TIP IN ABDOMEN NOTED.¿ THE TUBE WAS BEING USED FOR FEEDING AND MEDICATION ADMINISTRATION.

  Patient problems: Insufficient Information

  MAUDE report 25366907 ↗
• MalfunctionApr 26, 2024Fracture; Malposition of Device; Fracture; Malposition of Device

  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 9611594-2024-00069 FOR THE FIRST REPORT. REFER TO 9611594-2024-00070 FOR THE SECOND REPORT. REFER TO 9611594-2024-00071 FOR THE THIRD REPORT. IT WAS REPORTED, TUBE FRACTURED, LEAVING A PORTION OF THE TUBE IN THE PATIENT, REQUIRING ADDITIONAL INTERVENTION. PER ADDITIONAL INFORMATION RECEIVED ON 10-APR-2024, ¿THE TUBE WAS NOTICED TO BE MALPOSITIONED IN THE NARE. IMAGING WAS REQUESTED TO IDENTIFY PLACEMENT. THERE IS NO DOCUMENTATION THAT THE DEVICE HAD CLOGGED OR WAS DIFFICULT TO FLUSH IN ANY WAY. DEVICE INSERTED ON (B)(6) 2024- IMAGING REVEALED FRACTURE ON (B)(6) 2024. THE PORTION REMAINS RETAINED. CURRENT MEASURES ARE LAXATIVE AND DAILY IMAGING TO REVEAL ITS MOVEMENT. WE ARE UNSURE ANY ADDITIONAL INTERVENTIONS WHICH MAY BE REQUIRED.¿ FDA MEDWATCH/ FDA USER FACILITY REPORT NUMBER (B)(4) RECEIVED ON 23-APR-2024 REPORTED, ¿CORFLO DEVICE PLACED USING FLUOROSCOPY. IMAGING OBTAINED AFTER PLACEMENT REVEALED THE DEVICE HAD FRACTURED. THE TUBE WAS REMOVED, AND THE FRACTURED PIECE WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 19192334 ↗
• MalfunctionApr 26, 2024Material Puncture/Hole; Material Puncture/Hole

  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 9611594-2024-00069 FOR THE FIRST REPORT REFER TO 9611594-2024-00070 FOR THE SECOND REPORT REFER TO 9611594-2024-00072 FOR THE FOURTH REPORT IT WAS REPORTED, TUBES HAVE THE STYLET PUNCTURED THROUGH THE TUBE ITSELF. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, ¿PROVIDERS STATED THAT THEY WERE NOT OBSERVED TO BE PUNCTURED PRIOR TO INSERTION. THEY ARE EXAMINED AS LUBRICATION IS APPLIED.¿ FDA MEDWATCH/ FDA USER FACILITY REPORT NUMBER 1001510000-2024-8011 RECEIVED ON (B)(6) 2024 REPORTED, ¿STYLET PUNCTURED THROUGH THE TUBE DURING PLACEMENT. DEVICE NEEDED TO BE REMOVED AND REPLACED.¿ THE ORIGINAL INTENDED PROCEDURE WAS NASOGASTRIC TUBE PLACEMENT VIA FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192331 ↗
• MalfunctionApr 26, 2024Material Puncture/Hole; Material Puncture/Hole

  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 9611594-2024-00069 FOR THE FIRST REPORT. REFER TO 9611594-2024-00071 FOR THE THIRD REPORT . REFER TO 9611594-2024-00072 FOR THE FOURTH REPORT. IT WAS REPORTED, TUBES HAVE THE STYLET PUNCTURED THROUGH THE TUBE ITSELF. PER ADDITIONAL INFORMATION RECEIVED ON 10-APR-2024, ¿PROVIDERS STATED THAT THEY WERE NOT OBSERVED TO BE PUNCTURED PRIOR TO INSERTION. THEY ARE EXAMINED AS LUBRICATION IS APPLIED.". FDA MEDWATCH/ FDA USER FACILITY REPORT NUMBER (B)(4) RECEIVED ON 23-APR-2024 REPORTED, ¿STYLET PUNCTURED THROUGH THE TUBE DURING PLACEMENT. DEVICE NEEDED TO BE REMOVED AND REPLACED.¿ THE ORIGINAL INTENDED PROCEDURE WAS NASOGASTRIC TUBE PLACEMENT VIA FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192330 ↗
• MalfunctionApr 26, 2024Material Puncture/Hole; Material Puncture/Hole

  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 9611594-2024-00070 FOR THE SECOND REPORT . REFER TO 9611594-2024-00071 FOR THE THIRD REPORT . REFER TO 9611594-2024-00072 FOR THE FOURTH REPORT. IT WAS REPORTED, TUBES HAVE THE STYLET PUNCTURED THROUGH THE TUBE ITSELF. PER ADDITIONAL INFORMATION RECEIVED ON 10-APR-2024, ¿PROVIDERS STATED THAT THEY WERE NOT OBSERVED TO BE PUNCTURED PRIOR TO INSERTION. THEY ARE EXAMINED AS LUBRICATION IS APPLIED.". FDA MEDWATCH/ FDA USER FACILITY REPORT NUMBER (B)(4) RECEIVED ON 23-APR-2024 REPORTED, ¿STYLET PUNCTURED THROUGH THE TUBE DURING PLACEMENT. DEVICE NEEDED TO BE REMOVED AND REPLACED.¿ THE ORIGINAL INTENDED PROCEDURE WAS NASOGASTRIC TUBE PLACEMENT VIA FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192329 ↗
• MalfunctionMar 10, 2023Break; Break

  IT WAS REPORTED THE DEVICE BROKE AT THE END, "WE THINK WAS DUE TO USE OF CLOG BUSTER." THE PATIENT HAD TO BE TAKEN TO THE OR [OPERATING ROOM] FOR RETRIEVAL OF THE REMAINING PIECE." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16522754 ↗
• MalfunctionJun 19, 2022Break; Break

  IT WAS REPORTED THAT WHEN PLACING THE 10FR TUBE IN THE PATIENT¿S STOMACH, THE TIP POPPED OFF AND WAS LEFT IN THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED THAT NO MEDICAL INTERVENTION HAD BEEN PREFORMED ON THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED THAT THE PATIENT WAS STABLE WITH NO ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 14741327 ↗