AVANOS 44291Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00350770442914), received between Jul 9, 2021 and Apr 13, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Material Rupture

  THE CUSTOMER REPORTED THAT A 14 FRENCH MIC BOLUS GASTROSTOMY TUBE (BGT) WAS PLACED ON (B)(6) 2026. ON (B)(6) 2026, THE BALLOON WAS REPORTED TO HAVE BURST AFTER APPROXIMATELY 28 DAYS IN USE. THE TRACT WAS SALVAGED AND A REPLACEMENT 14 FRENCH BGT WAS SUCCESSFULLY REINSERTED. NO PATIENT INJURY WAS REPORTED; HOWEVER, IT WAS NOTED THAT THE STOMA SITE WAS RECENTLY ESTABLISHED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865116 ↗
• MalfunctionMar 20, 2026Complete Blockage

  IT WAS REPORTED "THE PERCUTANEOUS GASTROSTOMY VIA RADIOLOGY WAS PERFORMED ON DAY ZERO AT 10 A.M. IN INTERVENTIONAL RADIOLOGY AND INITIALLY PROCEEDED WITHOUT INCIDENT. UPON RETURN TO THE WARD, A 50CC WATER TEST WAS PERFORMED, FOLLOWED BY THE PASSAGE OF 500 CC OF WATER IN ACCORDANCE WITH THE PROTOCOL. AT 6 P.M., A MALFUNCTION OF THE PROBE OCCURRED, MAKING IT IMPOSSIBLE TO CIRCULATE WATER. AT 6 P.M., THE TUBE MALFUNCTIONED AND IT BECAME IMPOSSIBLE TO CIRCULATE WATER." "ATTEMPTS TO UNBLOCK THE TUBE WERE MADE BY THE REGISTERED NURSE. A CRACK WAS FOUND IN THE EXTERNAL TUBING OF THE TUBE. ON DAY ONE AT 10 A.M., THE PROBE WAS REPOSITIONED DURING A GASTROENTEROLOGY CONSULTATION BY THE ENDOSCOPY NURSE, WITH ANOTHER WATER TEST. IN THE EVENING (9 P.M.¿9:30 P.M.), A LEAK FROM THE GASTROSTOMY WAS OBSERVED. THE CT [COMPUTED TOMOGRAPHY] SCAN PERFORMED AT 11 P.M. REVEALED AN INTRAPERITONEAL POSITION OF THE TUBE AND ITS BALLOON, ASSOCIATED WITH INTRAPERITONEAL EFFUSION AND INHALATION PNEUMONITIS. GIVEN THE SIGNS OF PERITONITIS, EMERGENCY SURGERY WAS DECIDED AT MIDNIGHT AND PERFORMED AT 2 A.M." IT WAS CONCLUDED THERE WAS NO LINK BETWEEN THE REPORTED PRODUCT DEFECT AND THE PATIENT'S ¿INHALATION BRONCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656513 ↗
• MalfunctionFeb 27, 2026Migration or Expulsion of Device; Material Rupture

  IT WAS REPORTED, "WE HAD ANOTHER BURST BALLOON LAST WEEK - 3 DAYS POST INSERTION. PATIENT HAD 14FR MIC BGT INSERTED AS A NEW TUBE (B)(6) 2026. PATIENT CALLED HOTLINE DUE TO TUBE FALLING OUT (B)(6) 2026. ATTENDED A&E, ENPLUG PLACED BY A&E STAFF AS IT WAS THE WEEKEND ENPLUG NOT PLACED ALL THE WAY INTO THE STOMA, STOMA HAD ALREADY CLOSED HALFWAY DOWN. PATIENT REQUIRED ANOTHER RIG INSERTION (B)(6) 2026." THE STOMA SITE WAS ESTABLISHED (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24470917 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT A GASTROSTOMY TUBE WAS CHANGED ON (B)(6) 2026. CHECKED ON DAY 1 ((B)(6)), THE TUBE CAME OUT OF THE OPENING SPONTANEOUSLY, THE BALLOON APPEARED TO BE BURST. THE PATIENT HAD THE GASTROSTOMY IN (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED 15-JAN-2026 APPARENTLY, THE 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... CENTER DURING THE INCIDENT WITHOUT DIFFICULTY.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323724 ↗
• MalfunctionDec 23, 2025Deflation Problem; Device Dislodged or Dislocated; Deflation Problem; Device Dislodged or Dislocated

  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 9611594-2025-00334 FOR THE FIRST REPORT. IT WAS REPORTED, ¿THE DEPARTMENT REPORTS TWO CASES OF MALFUNCTIONING SNG PROBES THAT DEFLATED SPONTANEOUSLY. IN BOTH SITUATIONS, IMAGES TAKEN AT THE END OF THE PROCEDURE CONFIRM THAT THE PROBES WERE CORRECTLY POSITIONED." "PATIENT 2: THE SECOND PATIENT ENDED UP WITH THE TUBE, WITH THE BALLOON DEFLATED, OUTSIDE THE STOMA. THE BALLOON HAD CLEARLY NOT BEEN TESTED TO VERIFY ITS INTEGRITY. NO COMPLICATIONS WERE REPORTED FOR THIS CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882492 ↗
• MalfunctionDec 23, 2025Leak/Splash; Migration; Leak/Splash; Migration

  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 9611594-2025-00335 FOR THE SECOND REPORT. IT WAS REPORTED, ¿THE DEPARTMENT REPORTS TWO CASES OF MALFUNCTIONING SNG PROBES THAT DEFLATED SPONTANEOUSLY. IN BOTH SITUATIONS, IMAGES TAKEN AT THE END OF THE PROCEDURE CONFIRM THAT THE PROBES WERE CORRECTLY POSITIONED." ¿PATIENT 1: THE PATIENT SUFFERED FROM MIGRATION OF THE CATHETER INTO THE PERITONEAL CAVITY, WITH EXTRA-GASTRIC ADMINISTRATION OF HIS TREATMENT, LEADING TO PERITONITIS. HE WAS TRANSFERRED TO INTENSIVE CARE AND, AFTER SEVERAL DAYS OF TREATMENT, HIS CONDITION IMPROVED."

  Patient problems: Peritonitis

  MAUDE report 23882482 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED, ¿A GASTROSTOMY TUBE WAS PLACED IN THE PATIENT ON (B)(6) 2025 AT THE (B)(6) HOSPITAL. THE OPERATION WAS CARRIED OUT WITHOUT COMPLICATIONS. AN X-RAY EXAMINATION ON (B)(6) 2025 REVEALED NO ABNORMALITIES. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR RESPIRATORY PROBLEMS. ON THIS OCCASION, THE CATHETER WAS RINSED WITH NACL, AND ITS CORRECT POSITION WAS CHECKED. NO MAJOR PHYSICAL MANEUVERS WERE PERFORMED, AND THE CATHETER WAS NOT CONNECTED TO AN ADMINISTRATION SYSTEM (TUBING, PUMP). THE FOLLOWING MORNING, ON (B)(6) 2025, THE CATHETER WAS FOUND OUTSIDE THE PATIENT, IN HIS BED, WITH THE BALLOON BURST. THE PATIENT WILL REQUIRE SURGERY TO REPOSITION A GASTROSTOMY TUBE. IF TREATMENT HAD BEEN ADMINISTERED, UNDER-MEDICATION OR UNDER-NUTRITION COULD HAVE OCCURRED BETWEEN PROBE CHECKS.¿ PER ADDITIONAL INFORMATION RECEIVED ON 13MAY2025, ¿THE PROBE WAS USED ON A NEW STOMA SITE. THIS WAS THE FIRST PROBE FOR THIS PATIENT. THE PRODUCT WAS IN USE FROM ON (B)(6) 2025. THERE IS NO SIGN OF TRAUMA RELATED TO THE PRIMARY INCIDENT. A NEW PROBE HAD TO BE INSERTED.¿ THE PATIENT¿S STATUS IS ¿CONTINUATION OF CARE IN THE CONTEXT OF THE INITIAL REASON FOR HOSPITALIZATION, UNRELATED TO THE INCID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141169 ↗
• MalfunctionNov 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE ENTERAL FEEDING "TUBE OPENED ONE NIGHT, CAUSING A LEAK OF GASTRIC FLUID. THIS RESULTED IN A SECOND-DEGREE BURN AND SUBSEQUENT WOUND INFECTION...THIS RESULTED IN A SECOND-DEGREE BURN AND SUBSEQUENT WOUND INFECTION." ADDITIONAL INFORMATION RECEIVED 28-OCT-2024 STATED MEDICAL INTERVENTION INCLUDED "ANTIBIOTIC THERAPY WITH AMOXICILLIN 3X1G/D FROM (B)(6)2024, ANALGESIA WITH PARACETAMOL SINCE (B)(6)2024, LOCAL TREATMENT WITH FLAMMAZINE CREAM FROM (B)(6)2024." THE CURRENT CONDITION OF THE PATIENT IS, "EVER-PRESENT WOUNDS, DAILY DRESSINGS FOR OOZING AND SMELLY WOUNDS."

  Patient problems: Partial thickness (Second Degree) Burn; Wound Infection; Wound Odor

  MAUDE report 20750340 ↗
• MalfunctionJul 19, 2021Material Puncture/Hole; Migration; Material Puncture/Hole; Migration

  IT WAS REPORTED THAT THE GASTROSTOMY PROBE WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, A SCAN WAS PERFORMED WHICH SHOWED A MIGRATION OF THE PROBE. AFTER REMOVAL OF THE TUBE THE BALLOON WAS FOUND TO BE PIERCED. NO PATIENT INJURY WAS NOTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021 INDICATED THAT THE TIP OF THE PROBE WAS LOCATED OUTSIDE THE STOMACH; PHYSICIAN CONFIRMED IT WAS A PERITONEAL MIGRATION. THE ANCHORS WERE STILL IN PLACE. THE PATIENT'S CONDITION "WAS NOT ALTERED" AND A NEW PROBE WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189043 ↗
• InjuryJul 9, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THE GASTRIC PLUG WOULD NOT REMAIN CLOSED ON THE DEVICE. THE FAMILY MEMBER STATED, "ALMOST IMMEDIATELY" AFTER PLACEMENT THE GASTRIC PLUG ON THE MIC-G TUBE WILL NOT REMAIN CLOSED. THE GASTRIC LEAKAGE CAUSED THE SKIN TO BECOME IRRITATED. MUPIROCIN AND CALMOSEPTINE OINTMENT WERE PRESCRIBED TO TREAT THE SKIN IRRITATION. THERE WAS NO REPORTED INJURY.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 12143120 ↗