AVANOS 44573Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770445731), received between Oct 8, 2020 and Feb 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THERE WAS AN "OBSTRUCTION AND BREAKAGE OF THE JEJUNAL EXTENSION NEAR THE BALLOON DURING INFUSION OF THE MIXTURE INTO THE GASTRIC LUMEN.¿ ADDITIONAL INFORMATION CLARIFICATION RECEIVED 09-FEB-2026 NOTED THE USER "REPORTS OBSTRUCTION OF THE JEJUNAL EXTENSION, CAUSING RUPTURE OF THE JEJUNAL EXTENSION ITSELF AND THEREFORE LEAKAGE OF FLUID INTO THE GASTRIC LUMEN." NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472228 ↗
• MalfunctionDec 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE JEJUNAL LUMEN WAS LEAKING INTERNALLY (APPROXIMATELY 3CM FROM THE BALLOON). IT WAS CONFIRMED VIA TUBOGRAM. PATIENT REQUIRED MULTIPLE SHORT INTERNAL TUBE EXCHANGES DUE TO SMALL ISSUE. TUBE EXCHANGED FOR A NEW ONE. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18327695 ↗
• MalfunctionOct 8, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE IS A, "HOLE IN THE TUBE JUST UNDER FEED PORTS. ALSO 1 MONTH REPORTS OF MEDS [MEDICATION] GIVEN VIA JEJ, JEJUNAL PORT, APPEARING IN GASTRIC TUBE, AND GASTRIC DRAINAGE BAG." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 21-SEP-2020 INDICATED THE FEEDING TUBE WAS REPLACED IN INTERVENTIONAL RADIOLOGY. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 24-SEP-2020 IN THE FORM OF AN EVALUATION REPORT FROM THE DISTRIBUTOR INDICATED THE PRODUCT WAS IN USE FOR APPROXIMATELY 5 MONTHS. THE BALLOON WAS INFLATED USING 10ML OF COOLED, BOILED WATER. ACCORDING TO THE DISTRIBUTOR, NO OBVIOUS SIGNS OF MOLDING DEFORMITY OR MANUFACTURING MATERIAL WEAKNESS WERE IDENTIFIED. NO SIGN OF A LEAK FROM THE JEJUNAL LUMEN INTO THE GASTRIC LUMEN WAS IDENTIFIED. A TEAR WAS IDENTIFIED AT THE CONNECTION BETWEEN THE TUBING SECTION, AND THE FEED PORT SECTION OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648286 ↗