AVANOS 40-7366Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770460307), received between Dec 28, 2023 and Jun 16, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00444 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS FOUND TO HAVE SMALL HOLES JUST BELOW THE CONNECTOR AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518991 ↗
• MalfunctionJun 16, 2026Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00443 FOR THE FIRST REPORT. IT WAS REPORTED, UPON RECEIPT OF AN ADDITIONAL SAMPLE, THAT A NASOGASTRIC TUBE WAS FOUND TO HAVE SMALL HOLES JUST BELOW THE CONNECTOR AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518980 ↗
• MalfunctionJun 5, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT A SMALL PIN SIZE HOLE WAS DISCOVERED AT THE VERY TOP WHERE THE 2 PORTS ARE LOCATED. IT WAS ONLY DISCOVERED AFTER IT WAS PLACED IN THE BABY AND THEN THE TEAM NOTICED A LEAK AFTER FEEDS WERE INFUSING. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409389 ↗
• MalfunctionMar 13, 2026Fracture

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MDR REPORT KEY MW5182380 THE FOLLOWING: NG TUBE FRACTURED WHILE IN USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589273 ↗
• MalfunctionDec 10, 2025Break; Stretched; Obstruction of Flow; Break; Stretched; Obstruction of Flow

  THE FAILURE ANALYSIS LAB RECEIVED A NASOGASTRIC TUBE SAMPLE WITH CLOG/BALLOONED/TUBE BREAKS.

  Patient problems: Insufficient Information

  MAUDE report 23768588 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THE "THE TUBE WAS A STYLET TUBE.... FOLLOWING PATIENT EMESIS, PATIENT SNEEZED AND BROKEN OFF TIP OF NG [NASOGASTRIC] TUBE CAME OUT. REMAINDER OF NG WAS STILL SECURE IN THE PATIENTS NARE. REMOVED NG AND NOTED THAT END OF NG WAS FRAYED AND APPEARED TO HAVE BALLOONED OUT THEN BURST. PRIOR TO EMESIS, NG PLACEMENT WAS ABLE TO BE APPROPRIATELY VERIFIED WITH ASPIRATE AND PH TESTING BUT WOULD HAVE INTERMITTENT ISSUES WITH "NO FLOW OUT" ALARM FROM FEED PUMP DURING BOLUS FEEDS BUT WOULD FLUSH WITHOUT ISSUE. THE DEVICE WAS PLACED ON (B)(6) 2025 AND RUPTURED (B)(6) 2025. THE DEVICE WAS USED FOR BOLUS FEEDS AND MEDICATION ADMINISTRATION. ADDITIONAL INFORMATION RECEIVED 03-NOV-2025 STATED PATIENT IS STABLE. "NO SURGICAL INTERVENTION SINCE THE PIECE WAS SNEEZED OUT BY THE PATIENT." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23624998 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THE CORPAK TUBING THE HAD "BROKEN INSIDE OF THE PATIENT AND REQUIRED A PROCEDURE TO HAVE IT REMOVED." ADDITIONAL INFORMATION RECEIVED 05-DEC-2023 STATING "THE PATIENT IS OK." ADDITIONALLY, "AN ENDOSCOPY PROCEDURE WAS USED TO REMOVE THE SMALLER BROKEN PIECE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18414109 ↗