AVANOS 44559Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00350770445595), received between Nov 29, 2022 and Apr 14, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT'S FEEDING TUBE SNAPPED. THERE WAS A PIECE OF TUBE 4.5 CM LONG THAT HAD SNAPPED OFF. THE REMAINDER OF THE TUBE AND BALLOON ARE INSIDE PATIENT'S ABDOMEN. CARE STAFF INSERTED A NEW TUBE AND STARTED USING IT. THEY HAVE BEEN ADVISED TO STOP USING THE TUBE AND TO TAKE THE PATIENT TO ACCIDENT AND EMERGENCY SO THE REMNANTS OF THE BROKEN GASTROSTOMY TUBE CAN BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874137 ↗
• MalfunctionApr 8, 2026Malposition of Device

  IT WAS REPORTED THAT A "BALLOON WAS TOO SMALL (2-3 ML) AND AFTER A FEW DAYS IT MOVED TO THE INTRAPARIETAL POSITION IN THE PATIENT, CAUSING A LOT OF PAIN AND THE NEED TO CHANGE THE PROBE." ADDITIONAL INFORMATION RECEIVED 12-MAR-2026 STATED THIS WAS A NEWLY PLACED STOMA THAT CAUSED SOME INCONVENIENCES AFTER A FEW DAYS AND NEEDED TO BE CHANGED..."

  Patient problems: Pain

  MAUDE report 24818338 ↗
• MalfunctionFeb 9, 2026Migration or Expulsion of Device

  IT WAS REPORTED, PATIENT HAD A GASTROSTOMY IN (B)(6) 2025. THE TUBE FELL OUT AFTER THREE WEEKS AND IT WAS IMPOSSIBLE TO REINSERT IT THE NEXT DAY. SUBSEQUENTLY, THERE WAS PERSISTENT DISCHARGE FROM THE OPENING WITHOUT HEALING, SO THE TUBE WAS REINSERTED AT THE (B)(6). DURING THE INCIDENT WITHOUT DIFFICULTY.¿ PER ADDITIONAL INFORMATION RECEIVED 16JAN2026, ¿PATIENT WAS ADMITTED INTO (B)(6)., HAD A CT WHICH SHOWED THE MIC G TUBE HAD MIGRATED INTO THE PERITONEUM. SHE IS STILL ADMITTED AND IS WAITING TO GO BACK TO IR FOR ANOTHER INSERTION ON A MIC G TUBE.¿

  Patient problems: Fluid Discharge

  MAUDE report 24298182 ↗
• MalfunctionDec 9, 2025Material Rupture; Material Rupture

  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 9611594-2025-00312 FOR THE FIRST REPORT IT WAS REPORTED, THE FEEDING TUBE BALLOON BURST WITHIN SIX WEEKS POSTOP. PER ADDITIONAL INFORMATION RECEIVED ON 20NOV2025, A NEW TUBE WAS INSERTED UNDER GENERAL ANESTHESIA. THE PATIENT HAS MANY POSTOPERATIVE PROBLEMS WITH A WOUND INFECTION DUE TO THE ABOVE PROBLEM.

  Patient problems: Wound Infection

  MAUDE report 23761485 ↗
• MalfunctionDec 9, 2025Material Rupture; Material Rupture

  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 (B)(4) FOR THE SECOND REPORT. IT WAS REPORTED, THE FEEDING TUBE BALLOON BURST WITHIN SIX WEEKS POSTOP. PER ADDITIONAL INFORMATION RECEIVED ON 20NOV2025, A NEW TUBE WAS INSERTED UNDER GENERAL ANESTHESIA. THE PATIENT IS DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 23761480 ↗
• MalfunctionOct 24, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) FEEDING TUBE FEEDING TUBE WAS PLACED ON (B)(6) 2025 FELL OUT ON (B)(6) 2025 DUE TO A DEFLATED BALLOON. THE THREE ANCHOR SUTURES REMAIN "INSITU." THE PATIENT HAS AGREED TO AN ATTEMPT TO REINSERT THE TUBE UNDER LOCAL ANESTHETIC. THE CLINICAL NURSE SPECIALIST (CNS) USUALLY WILL VISIT THE PATIENT NEXT DAY TO GIVE ADVICE ON HOW TO MANAGE THE TUBE AT HOME AND THE CARE OF THE TUBE. FOLLOW-UP CONFIRMED THE BALLOON WAS COMPLETELY DEFLATED; IT WAS DIFFICULT TO SEE IF THERE WAS ANY REMAINING WATER IN THE BALLOON. THERE WERE NO REPORTS OF THE PATIENT FALLING OR CATCHING THE DEVICE ON THE WARD. THE CLINICIAN HAD TAKEN THE INTERVENTION RADIOLOGY (IR) DRESSING DOWN TO CHECK SITE. THE CLINICIAN SLOWLY FLUSHED TO OBSERVE FOR ANY LEAKAGE, THERE WAS NONE. THE CLINICIAN THEN COMMENCED SOME TRAINING WITH THE PATIENT, THE PATIENT WAS UNDER DIRECT SUPERVISION, THE PATIENT THEN OPENED THE ADAPTOR, CONNECTED THE SYRINGE SMOOTHLY AND GENTLY, THE PATIENT STARTED FLUSHING WITH WATER, WHEN THE CLINICIAN NOTICED WATER LEAKING ONTO ABDOMEN, REALIZING THAT THE RIG HAD FALLEN OUT, THE BALLOON WAS COMPLETELY DEFLATED. THE THREE ANCHOR SUTURES REMAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376669 ↗
• MalfunctionNov 29, 2022Material Integrity Problem; Material Integrity Problem

  FDA USER FACILITY MEDWATCH REPORT FDA MW (B)(4) REPORTED, THE TUBING OF THE PATIENT'S PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE SNAPPED OFF AT THE HUB DURING FEEDING. THE TUBE HAD BEEN IN PLACE FOR (2) TWO WEEKS; THE SURGICAL TEAM TO COME TO THE BEDSIDE TO REPLACE IT; THERE WAS NO REPORTED INJURY TO THE PATIENT WHO COULD ONLY RECEIVE NUTRITION THROUGH BOLUS TUBE FEEDING. ADDITIONAL INFORMATION RECEIVED 04NOV2022 REPORTED, THE INFANT WAS DISCHARGED AND WAS SLOWLY PROGRESSING.

  Patient problems: Feeding Problem

  MAUDE report 15880881 ↗