AVANOS 44560Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00350770445601), received between Feb 12, 2021 and Sep 28, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Material Rupture; Migration

  It was reported that a patient underwent primary gastrostomy insertion with no immediate complications reported. The balloon was seen to be inflated at the end of the procedure. Two days later, he had a CT abdomen and pelvis due to acute abdominal pain that showed the balloon to be deflated and the gastrostomy was partially withdrawn (the tip was just within the stomach). That night, they exchanged the gastrostomy tube as an emergency case in IR. The balloon had ruptured. The tube was replaced, and the patient's pain eased quickly.

  Patient problems: Abdominal Pain

  MAUDE report 50915853 ↗
• MalfunctionMay 4, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT HAD RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) INSERTED (B)(6) 2026. ON (B)(6) 2026, THE RIG HAD A BURST BALLOON. ONE DAY OVER THE FOUR WEEKS POST INSERTION SO IT WAS ABLE TO BE CHANGED BY NUTRITIONAL NURSES IN GLU CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068140 ↗
• MalfunctionApr 7, 2026Migration or Expulsion of Device

  THE CUSTOMER REPORTED ¿GASTROSTOMY TUBE INSERTED ON (B)(6) 2026. ON (B)(6) 2026, DISLOCATION DUE TO TEAR IN THE BALLOON.¿ THE DEVICE HAD BEEN IN USE FOR 2 DAYS WHEN THE BALLOON FAILURE OCCURRED, RESULTING IN TUBE DISLODGEMENT. THE PATIENT EXPERIENCED PAIN AND REQUIRED REPLACEMENT OF THE GASTROSTOMY TUBE, INCLUDING AN ADDITIONAL ENDOSCOPIC PROCEDURE UNDER INTUBATION ANESTHESIA. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. THE PATIENT¿S CONDITION WAS REPORTED AS STABLE.

  Patient problems: Pain

  MAUDE report 24802368 ↗
• MalfunctionFeb 3, 2026Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00030 FOR THE FIRST EVENT. REFER TO 9611594-2026-00032 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE CUSTOMER HAS HAD A LOT OF BALLOON FAILURES OF THEIR MIC BGT (BALLOON GASTROSTOMY TUBE) IN THE LAST COUPLE OF MONTHS. MANY OF THEM HAVE BEEN WITHIN THE FIRST FEW WEEKS OF INITIAL PLACEMENT. NO ADDITIONAL INFORMATION PROVIDED YET. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251532 ↗
• MalfunctionFeb 3, 2026Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2026-00031 FOR THE THIRD EVENT. REFER TO 9611594-2026-00032 FOR THE FOURTH EVENT. IT WAS REPORTED THERE WAS A BALLOON FAILURE OF THE MIC BGT (BALLOON GASTROSTOMY TUBE). THE DEVICE REPORTABLE FAILED WITHIN THE FIRST FEW WEEKS OF INITIAL PLACEMENT. NO ADDITIONAL INFORMATION PROVIDED YET. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251531 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00281 FOR THE FIRST EVENT. IT WAS REPORTED THAT THE PATIENT HAD A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PLACED INITIALLY ON (B)(6) 2025 WHICH WAS SUCCESSFUL. ON (B)(6) 2025 THE RIG WAS "REPORTED TO BE LEAKING. ON ASSESSMENT, THE BALLOON HAD FAILED AND SUBSEQUENTLY FELL OUT OF TRACT. REPEAT RIG PROCEDURE NOW REQUIRED." THE PATIENT WAS RECEIVING INTRAVENOUS (IV) FLUIDS, IV ANTIBIOTICS AND A NASOGASTRIC (NG) DRAINAGE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601047 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO (B)(4) FOR THE SECOND EVENT. IT WAS REPORTED THAT THE PATIENT HAD A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PLACED INITIALLY ON (B)(6) 2025. AT THE END OF THE PROCEDURE THE DEVICE BALLOON WAS NOTICED TO HAVE BURST. THE TUBE WAS "REMOVED BUT UNABLE TO RECANNULATE THE TRACT. ABANDONED PROCEDURE." THE PATIENT WAS RECEIVING INTRAVENOUS (IV) FLUIDS, IV ANTIBIOTICS AND A NASOGASTRIC (NG) DRAINAGE TUBE. THE PATIENT REQUIRED A REPEAT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601043 ↗
• MalfunctionNov 13, 2025Burst Container or Vessel; Malposition of Device; Burst Container or Vessel; Malposition of Device

  IT IS REPORTED THAT A BALLOON GASTROSTOMY TUBE FAILED WITHIN 24-HOURS OF RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PROCEDURE. THERE WAS NO REPORTED INJURY ADDITIONAL INFORMATION RECEIVED 17-OCT-2025 STATED "RIG PROCEDURE COMPLETED ON (B)(6) 2025, CNS [CLINICAL NURSE SPECIALIST] NUTRITION REVIEW THE FOLLOWING DAY AND THE GASTROSTOMY TUBE HAD DISPLACED AND FELL OUT OF THE GASTROSTOMY TRACT WHEN THE DRESSING WAS REMOVED ON (B)(6) 2025. NEW GASTROSTOMY TUBE SITED AND CONTRAST STUDY PERFORMED TO CONFIRM GASTRIC POSITION UNDER FLUOROSCOPIC GUIDANCE. PATIENT DISCHARGED AND WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547928 ↗
• MalfunctionJul 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED, ¿MIC BOLUS 14FR GASTROSTOMY BALLOON BURST THIS MORNING. THE RIG WAS INSERTED (B)(6) 2025 WITH 4MLS OF STERILE WATER, THIS IS A NEW STOMA SITE NOT A REPLACEMENT.¿ PER ADDITIONAL INFORMATION RECEIVED ON 3JUL2025, ¿THE INDIVIDUAL IS CURRENTLY AN INPATIENT, THE MEDICAL TEAM WERE ALERTED AND REVIEWED THE PATIENT. PAIN RELIEF WAS PROVIDED, AN ENPLUG WAS INSERTED AND REPLACEMENT TUBE.¿ NO ISSUES WITH TUBE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563857 ↗
• MalfunctionNov 13, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00252 FOR THE FIRST EVENT. REFER TO 9611594-2024-00253 FOR THE SECOND EVENT. IT WAS REPORTED THERE WAS SLIPPING OF THE EXTERNAL RETENTION DEVICE CAUSING THE BALLON TO MOVE POST PYLORIC AND CAUSE OBSTRUCTION. THE DEVICE WAS INSERTED (B)(6) 2024. THE PATIENT PRESENTED TO THE [EMERGENCY DEPARTMENT] ED (B)(6) 2024 WITH SITE IRRITATION AND NOTED DISC SLIPPED UP, AND IT WAS ADJUSTED. THE PATIENT WAS SCHEDULED FOR A PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] CLINIC FOLLOW-UP VISIT IN WHICH THE CLINICIAN WOULD APPLY TAPE ABOVE THE SLIPPING DISC. ADDITIONAL INFORMATION RECEIVED 22-OCT-2024 STATING THE DEVICE WAS ADJUSTED AND TAPING ABOVE DISC WAS APPLIED. THE PATIENT WAS ADVISED TO MONITOR THE NUMBER ON TUBE WHERE DISC IS SITTING. THE PATIENT'S WELL. THE DEVICE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678216 ↗
• MalfunctionNov 13, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00252 FOR THE FIRST EVENT. REFER TO 9611594-2024-00254 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS SLIPPING OF THE EXTERNAL RETENTION DEVICE CAUSING THE BALLOON TO MOVE POST PYLORIC AND CAUSE OBSTRUCTION. THE DEVICE WAS INSERTED (B)(6)2024. THERE WAS AN ISSUE NOTED WITH DISC SLIPPING AT 2-WEEK POST-OP FOLLOW-UP (TELEHEALTH). THEN 15-DAYS LATER DISC NOTED TO BE AT 8CM AND ADJUSTED. THEN 2-WEEKS LATER AGAIN DUE FOR CHANGE TO BUTTON BUT NOTED DISC UNABLE TO BE REDUCE TO LESS THAN 4CM. NOT CHANGED TO BUTTON DUE TO CONCERNS WITH TRACT FORMATION DUE TO SLIPPING DISC EARLY ON. REQUIRED BARIUM AND NOT TO USE DEVICE." ADDITIONAL INFORMATION RECEIVED (B)(6)2024 STATING THE PATIENT WAS "SENT FOR PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] O-GRAM TO CHECK FOR LEAK AND NIL BY PEG. THE PATIENT'S IS UNKNOWN BUT ASSUMED TO BE WELL. THE DEVICE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678198 ↗
• MalfunctionNov 13, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00253 FOR THE SECOND EVENT. REFER TO 9611594-2024-00254 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS SLIPPING OF THE EXTERNAL RETENTION DEVICE CAUSING THE BALLOON TO MOVE POST PYLORIC AND CAUSE OBSTRUCTION. THE DEVICE WAS PLACED (B)(6) 2024 AND DURING THE PATIENT'S 6-WEEK FOLLOW UP THE ENTERAL FEEDING DEVICE "DISC MOVED DOWN TO 2 CM. ABOUT 20-DAYS LATER, THE PATIENT WAS ADMITTED WITH GASTRIC OUTLET OBSTRUCTION AND PNEUMOPERITONEUM WITH MOBILIZED DISC." ADDITIONAL INFORMATION RECEIVED 22-OCT-2024 STATING THE PATIENT WAS "ADMITTED TO HOSPITAL. TRANSFER[ED] TO *(B)(6) HOSPITAL. REVIEW BY SURGICAL TEAM. MEDICALLY MANAGED WITH [NASOGASTRIC TUBE] NGT, NIL BY MOUTH AND ANTIBIOTICS." THE PATIENT IS REPORTED TO BE WELL. THE DEVICE REMAINS IN USE.

  Patient problems: Obstruction/Occlusion; Pneumoperitoneum

  MAUDE report 20678025 ↗
• InjuryJul 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, "BALLOON FAILED, FLUID EXITING VIA FEED LUMEN. TUBE PLACED ON (B)(6) 2024. PATIENT COMPLAINED OF PAIN. CT SCAN CONFIRMED TIP OF TUBE IN STOMACH, ON RETURN TUBE HAD FALLEN OUT WITH EMPTY BALLOON ON (B)(6) 2024. TUBE RETAINED AND RENEWED INTERNALLY, FLUID LEAKING INTO FEED LUMEN. PATIENT REQUIRED OBSERVATION FOR PERITONITIS, ELONGATED HOSPITAL STAY AND POST-PYLORIC FEEDING WHILE AT RISK OF PERITONITIS. HAS NOW HAD A FURTHER PROCEDURE FOR POST PYLORIC FEEDING AND SINCE THEN ANOTHER RIG PROCEDURE.¿ PER ADDITIONAL INFORMATION RECEIVED ON 09JUL2024, ¿NO PERITONITIS, JUST RISK OF, PLUS MONITORING AND SIGNIFICANT PAIN.¿

  Patient problems: Pain

  MAUDE report 19829573 ↗
• InjuryNov 2, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS INITIALLY REPORTED, THE PATIENT ATTENDED THE EMERGENCY DEPARTMENT AS THE TUBE FELL OUT FROM THE BALLOON BEING SPLIT. PER ADDITIONAL INFORMATION RECEIVED ON 16OCT2023, A 14FR MIC GASTRONOMY BALLOON TUBE WAS USED WITH A MIC INTRODUCER KIT. THE LOCATION OF THE SPLIT WAS ON THE STEM OF BALLOON. THE TUBE WAS INSERTED ON (B)(6) 2023. UNABLE TO REPLACE TUBE INTO TRACT ENTERING PERITONEAL CAVITY. PATIENT WAS TREATED AS ¿GASTRIC PERFORATION¿. THE PATIENT REMAINED NOTHING BY MOUTH AND NASOJEJUNAL TUBE FED UNTIL "GASTRIC PERFORATION" HEALED FOR GASTROGRAFFIN STUDY TO CHECK FOR HEALING 1-2 WEEKS. DELAYED TREATMENT FOR CANCER REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18061085 ↗
• InjuryFeb 12, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE STOMA SITE OF THE PATIENT WAS INFECTED AND EXCORIATED UNDER THE DISK OF THE MIC G TUBE. THE PRESCRIBED TREATMENT WAS BACTOBAN CREAM AND KENDALL DRESSINGS. PER ADDITIONAL INFORMATION RECEIVED 25 JAN 2021, THE PATIENT IS CURRENTLY ON ANTIBIOTICS FOR TREATMENT. PER ADDITIONAL INFORMATION RECEIVED 01 FEB 2021, THE PATIENT'S TUBE WAS CHANGED OUT WITHOUT ISSUE. THE PATIENT WAS HAPPY TO BE TRAINED IN 6 AND 9 MONTHS- TO BE ARRANGED. PATIENT IS FINE IN BVC (BALLOON VOLUME CHECK) AND PH."

  Patient problems: Skin Infection

  MAUDE report 11323278 ↗