AVANOS 44577Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770445779), received between Feb 25, 2026 and Jun 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Expulsion” (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.

• MalfunctionJun 23, 2026Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED, "PATIENT WITH PARKINSON¿S DISEASE CARRYING A GASTROJEJUNOSTOMY TUBE SINCE 2026-03-30 FOR THE ADMINISTRATION OF DUODOPA TREATMENT. ON (B)(6) 2026, PERFORATION OF THE TUBE BALLOON CAUSED LEAKAGE OF GASTRIC FLUID, RESULTING IN SUPERFICIAL PERI -STOMAL SKIN BURNS. A REPEAT PROCEDURE WAS PERFORMED ON (B)(6) 2026 FOR PLACEMENT OF A REPLACEMENT TUBE." PER ADDITIONAL INFORMATION RECEIVED ON 2026-05-28, "THE FOLLOW-UP PROCEDURE TOOK PLACE ON (B)(6) 2026, TO INSERT A REPLACEMENT CATHETER."

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25594954 ↗
• MalfunctionApr 23, 2026Expulsion

  IT WAS REPORTED THAT AN 83-YEAR-OLD PATIENT WHO HAS HAD A GASTROJEJUNOSTOMY TUBE IN PLACE SINCE (B)(6) 2025, FOR ENTERAL NUTRITION AND DUODOPA ADMINISTRATION. ON (B)(6) 2026, HE NOTICED AT HOME THAT THE TUBE HAD ACCIDENTALLY SLIPPED OUT. THE TUBE WAS SUCCESSFULLY REINSERTED INTO THE STOMACH AT HOME. THE PATIENT WAS RECALLED FOR AN EMERGENCY CONSULTATION TO HAVE A SIMPLE GASTROSTOMY TUBE WITH A BALLOON INFLATED TO 10 CC OF WATER PLACED IN ORDER TO RESUME TREATMENT. A SURGICAL INTERVENTION IS SCHEDULED LATER TO REPOSITION A GASTROJEJUNAL TUBE. IF, IN THE MEANTIME, THE PATIENT FINDS THAT THE EFFECTIVENESS IS JUST AS GOOD WITH THE GASTRIC TUBE, THE APPOINTMENT WILL BE CANCELLED, AND THE DEVICE COULD BE CHANGED EVERY 6 MONTHS DURING A ROUTINE CONSULTATION. ON (B)(6) 2026 IT WAS CONFIRMED TO RELATE TO A NEW STOMA SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975121 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED, ¿OBSTRUCTION AND BREAKAGE OF THE JEJUNAL EXTENSION NEAR THE BALLOON DURING INFUSION OF THE MIXTURE INTO THE GASTRIC LUMEN.¿ PER CLARIFICATION REPORTED ON (B)(6) 2026, "THE CUSTOMER REPORTS OBSTRUCTION OF THE JEJUNAL EXTENSION, CAUSING RUPTURE OF THE JEJUNAL EXTENSION ITSELF AND THEREFORE LEAKAGE OF FLUID INTO THE GASTRIC LUMEN." NO INJURY REPORTED.

  Patient problems: Feeding Problem

  MAUDE report 24442421 ↗