AVANOS 44293Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00350770442938), received between May 5, 2020 and Jan 28, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Material Puncture/Hole

  IT WAS REPORTED, "75-YEAR-OLD FEMALE PATIENT WITH A GPE CATHETER INSERTED ON (B)(6) 2025, AS PART OF DUODOPA TREATMENT FOR SEVERE PARKINSON'S DISEASE. ON (B)(6) 2025, LOSS OF EQUIPMENT DURING NURSING CARE WITH OBSERVATION OF A PUNCTURED BALLOON, TEMPORARY PLACEMENT OF A 16FR URINARY CATHETER AT HOME. ADMITTED TO DAY HOSPITAL ON (B)(6) 2025 FOR DILATION OF THE ORIFICE AND PLACEMENT OF AN 18FR GASTROSTOMY TUBE IN ORDER TO CONTINUE TREATMENT WITH DUODOPA AND ENTERAL NUTRITION. SCHEDULED FOR UPCOMING DAY HOSPITALIZATION FOR ENDOSCOPIC PLACEMENT OF A NEW GASTROJEJUNAL TUBE."

  Patient problems: Insufficient Information

  MAUDE report 24199504 ↗
• MalfunctionJan 26, 2026Material Rupture

  IT WAS REPORTED, "59-YEAR-OLD FEMALE PATIENT RECEIVING DUODOPA TREATMENT VIA AN 18FR GASTROJUNAL TUBE INSERTED ON (B)(6) 2025 FOR PARKINSON'S DISEASE. ON (B)(6) 2025, TOTAL LOSS OF THE TUBE DUE TO A PUNCTURED BALLOON. ADMITTED TO THE EMERGENCY ROOM AT (B)(6) FOR TEMPORARY PLACEMENT OF A 14CH URINARY CATHETER. ADMITTED TO DAY HOSPITAL ON (B)(6) 2025 FOR GRADUAL DILATION OF THE ORIFICE AND PLACEMENT OF AN 18FR GASTROSTOMY TUBE IN ORDER TO RESUME TREATMENT WITH DUODOPA. FUTURE APPOINTMENT AT DAY HOSPITAL SCHEDULED FOR NEW ENDOSCOPIC PLACEMENT OF A GASTRODUODENAL TUBE."

  Patient problems: Insufficient Information

  MAUDE report 24183231 ↗
• MalfunctionSep 11, 2025Unintended Movement; Unintended Movement

  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 9611594-2025-00205 FOR THE FIRST EVENT. IT WAS REPORTED THERE WAS AN EVENT IN WHICH THERE WAS A "NEW GASTROSTOMY INSERTION IN A PATIENT DESCRIBING THE EXACT SAME EPISODE OF AN EXTERNALIZED TUBE WITHOUT REASON." THE DEVICE WAS INITIALLY INSERTED ON (B)(6) 2025. THE PATIENT REQUIRED A "NEW GASTROSTOMY SINCE THE FIRST PROBE FELL OUT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026794 ↗
• MalfunctionSep 11, 2025Unintended Movement; Unintended Movement

  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 9611594-2025-00206 FOR THE SECOND EVENT. IT WAS REPORTED BY THE MEDICAL IMAGING DEPARTMENT THE GASTROSTOMY DEVICE WAS INSERTED ON (B)(6) 2025. THE POST-PROCEDURE CHECK-UP WAS SATISFACTORY. THE PATIENT EXPERIENCED A PAINFUL WATER TEST AT HOUR SIX POST ON OPERATIVE DAY ONE AND THE FOLLOWING DAY. AT THE CHECK-UP ON (B)(6) 2025 THE "GASTROSTOMY TUBE EXTERIORIZED WITHOUT ANY MANIPULATION (EXCEPT FOR WATER TEST). THE BALLOON WAS DEFLATED. THE BALLOON TEST ON TUBE WAS FUNCTIONAL, BUT AT PAST HOUR 2 THE BALLOON DEFLATED." ADDITIONAL INFORMATION RECEIVED ON 14-AUG-2025 STATING THE PATIENT REQUIRED THE PERCUTANEOUS GASTROSTOMY BECAUSE "OF SQUAMOUS CELL CARCINOMA OF THE ROOT OF THE TONGUE TREATED BY OROPHARYNGEAL AND PELVIC LATERAL SQUAMOUS CELL CARCINOMA, TRACHEOSTOMY, AND RIGHT NECK DISSECTION WITH A HIGH PROBABILITY OF RADIOTHERAPY TREATMENT BEING CONSIDERED." THE PATIENT REQUIRED A "NEW GASTROSTOMY SINCE THE FIRST PROBE FELL OUT." THERE WAS NO REPORTED INJURY.

  Patient problems: Pain

  MAUDE report 23026786 ↗
• MalfunctionSep 3, 2025Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  IT WAS REPORTED "THAT FOUR DAYS AFTER THE INITIAL PLACEMENT OF A FEEDING TUBE, THE FEEDING TUBE FELL OUT OF THE STOMA." THE PHYSICIAN REPLACED THE DEVICE WITH A NEW DEVICE TO CONTINUE FEEDING THE PATIENT. ADDITIONAL INFORMATION RECEIVED 07-AUG-2025 STATED WHEN THE STOMA SITE STARTED TO CLOSE THE PROVIDER INSERTED A FOLEY CATHETER TO PREVENT THE STOMA SITE FROM CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954530 ↗
• MalfunctionJul 18, 2025Misconnection; Misconnection

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5168197 THE FOLLOWING INFORMATION: ON (B)(6) 2025, THIS PATIENT HAD A GASTROSTOMY TUBE PLACED IN THE OPERATING ROOM WITH ORDERS FOR GTUBE TO GRAVITY DRAINAGE. IN SETTING UP THE TUBE TO GRAVITY DRAINAGE, THE NURSE SELECTED THE INCORRECT BAG. THE BAG THAT WAS USED WAS A NEPHROSTOMY BAG PRODUCT URESIL REF TC600.THIS BAG WAS INCORRECTLY ATTACHED TO THE GTUBE BALLOON PORT AND RESULTED IN THE DEFLATION OF THE BALLOON AND RESULTED IN THE DISLODGEMENT OF THE TUBE. ON (B)(6)2025, THE PATIENT RETURNED TO THE OPERATING ROOM TO HAVE THE GTUBE REPLACED. ALTHOUGH THERE IS NO DEVICE ERROR, THAT CONTRIBUTED TO HARM, IT WAS NOTED IN THE REVIEW OF THE EVENT THAT THERE IS NO VISUAL INDICATOR OR COLOR CODING FOR THE FEEDING PORTS OR THE BALLOON PORTS. REPORTING TO MAKE THE RECOMMENDATION FOR VISUAL INDICATOR TO DIFFERENTIATE THESE PORTS. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS 18 F REF 8100-18.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544137 ↗
• MalfunctionNov 8, 2024Misconnection; Malposition of Device; Misconnection; Malposition of Device

  PER ADDITIONAL INFORMATION RECEIVED ON 12FEB2025, FEED WAS INITIATED ON (B)(6) 2024 AND THE CT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Abdominal Pain; Pneumoperitoneum

  MAUDE report 20644790 ↗
• MalfunctionNov 8, 2024Break; Break

  PER ADDITIONAL INFORMATION RECEIVED ON 18DEC2024, THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20644463 ↗
• InjuryJun 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE CAP ¿POPS¿ OFF AND GASTRIC FLUID LEAKS OUT, CAUSING QUITE SERIOUS LESIONS ON THE SKIN. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, TUBE WAS REPLACED WITH ONE FROM ANOTHER MANUFACTURER AND THE BURN INJURIES WERE TREATED WITH ANTISEPTIC AND HEALING CREAM. THE PATIENT¿S STATUS WAS REPORTED ¿STABLE STATE AND THE BURN INJURIES WERE ALMOST ELIMINATED TODAY.¿ PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, ANTISEPTIC AND HEALING CREAM WERE PRESCRIBED PRODUCTS AND NOT OVER-THE-COUNTER PRODUCTS.

  Patient problems: Localized Skin Lesion

  MAUDE report 19574530 ↗
• MalfunctionJun 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, GASTRIC FLUID LEAKED FROM GASTRONOMY TUBE. STOMA SITE APPEARS TO HAVE "BURNS AND PHLYCTENS." TREATMENT INCLUDES EFFIDIA OINTMENT AND DRY COMPRESSES. PER ADDITIONAL INFORMATION RECEIVED ON 21MAY2024, ¿THE PATIENT IS CURRENTLY DOING WELL. HIS SKIN CONDITION IS GOOD BUT REMAINS UNDER SURVEILLANCE DUE TO BURNS CAUSED BY GASTRIC FLUID. THE FEEDING TUBE HAS BEEN IN PLACE FOR 3 MONTHS AND IS DUE TO BE CHANGED IN MID-(B)(6).¿

  Patient problems: Burn(s)

  MAUDE report 19478252 ↗
• MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE "BALLOON WAS INFLATED AND CONTRAST INJECTION TO CONFIRM LOCATION. AS THE PATIENT IS LEAVING ROOM, NURSE NOTED NO OUTPUT FROM TUBE AND PT WAS VOMITING BILIOUS MATERIAL. PATIENT PLACED ON TABLE AND SCOUT FILM DEMONSTRATED BALLOON NOT INFLATED AND CONTRAST INJECTION DEMONSTRATED TO BE IN PERITONEUM. ATTEMPTED TO RE-CANNULATE HOLE BUT UNABLE. NEW TUBE PUT IN PLACE. UPON EXAMINING THE 'G' TUBE, THE BALLOON HAS A LEAK. EXPLAINING ABOVE FINDINGS. THE PATIENT HAD TO BE ADMITTED TO THE HOSPITAL AND RECEIVED ADDITIONAL CARE (CT¿S [COMPUTED TOMOGRAPHY'S] AND A MULTITUDE OF CONSULTATIONS AND CARE) DUE TO A DEFECTIVE PRODUCT." THERE WAS NO REPORTED INJURY.

  Patient problems: Vomiting

  MAUDE report 18004504 ↗
• MalfunctionApr 24, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THE "NURSE WAS PROVIDING MEDICATIONS AND [PATIENT] HEARD 'LOUD POP' AND TUBE STARTED TO COME OUT. TRANSFERRED TO IR (INTERVENTIONAL RADIOLOGY) AND BALLOON WAS RUPTURED." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 STATED "THE PATIENT HAD AN UPPER GI (GASTROINTESTINAL) BLEED FROM HER GASTRIC REMNANT WHERE THE GASTROSTOMY TUBE WAS ENTERING THE STOMACH. IR WAS UNABLE TO EMBOLIZE THE BLEED. PATIENT (RECEIVING ANTICOAGULANT THERAPY AT HOME) ADMITTED TO HOSPITAL (B)(6) 2023 DUE TO HOME CARE NURSE REPORTING BLOOD-SOAKED DRESSING AROUND FEEDING TUBE SITE. THE PATIENT EXPERIENCED DIZZINESS STATUS POST PARTIAL GASTRECTOMY, OPEN SPLENECTOMY, TRANS HIATAL ESOPHAGECTOMY WITH CERVICAL ESOPHAGOSTOMY DUE TO RECENT HOSPITALIZATION FOR A GI BLEED. WHILE PATIENT WAS THE IN THE ER (EMERGENCY ROOM) THE RN (REGISTERED NURSE) WAS ADMINISTERING MEDICATIONS THROUGH THE BALLOON INFLATION PORT OF THE FEEDING TUBE WHEN SHE HEARD A "LOUD POP" AND "THE TUBE STARTED TO COME OUT". AFTER THE LOUD POP WAS HEARD, THE PATIENT TAKEN TO CT (COMPUTED TOMOGRAPHY) FOR A CAT SCAN OF THE ABDOMEN. THE CAT SCAN REVEALED "AN ACTIVE ARTERIAL BLEED AROUND GASTROSTOMY BALLOON INSERTIO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16799480 ↗
• InjuryJun 12, 2020Break; Migration; Break; Migration

  AN FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT HAD PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT. PER THE OP NOTE: "UNDER ENDOSCOPIC VISUALIZATION 3 T-FASTENERS WERE PLACED PERCUTANEOUSLY SECURING THE ANTERIOR GASTRIC WALL AGAINST AND TO ABDOMINAL WALL. A 1 CM INCISION WAS CREATED BETWEEN THESE FASTENERS AND CARRIED ON DOWN THROUGH THE RECTUS FASCIA. AN 18-GAUGE NEEDLE WAS PLACED THROUGH THIS INCISION FOLLOWED BY J-WIRE USING SELDINGER TECHNIQUE. UNDER ENDOSCOPIC VISUALIZATION A LARGE DILATOR AND SHEATH WAS PASSED OVER THE WIRE. THE WIRE AND THE DILATOR WAS REMOVED LEAVING THE SHEATH IN PLACE. 18 FRENCH G-TUBE WAS ADVANCED THROUGH THE SHEATH AND THE BALLOON WAS INFLATED WITH 10 CC OF SALINE AND BROUGHT BACK AGAINST AND TO ABDOMINAL WALL." ONCE HE WAS TOLERATING TUBE FEEDINGS , HE WAS DISCHARGED HOME THREE DAYS AFTER. THE FOLLOWING MORNING , PATIENT AWOKE WITH ABDOMINAL PAIN. IN THE ED, CT SHOWED: "G-TUBE IS NOTED POSITIONED IN THE STOMACH. NOTE IS MADE OF PUNCTATE EXTRALUMINAL AIR TO THE RIGHT OF THE G-TUBE TRACT WITH SMALL AMOUNT OF FLUID ALSO EVIDENT." ONCE ADMITTED TO FLOOR , AS HE WAS COMING OUT OF THE

  Patient problems: No Code Available

  MAUDE report 10148482 ↗
• InjuryMay 5, 2020Fluid/Blood Leak; Malposition of Device; Fluid/Blood Leak; Malposition of Device

  PER FDA MEDWATCH/USER FACILITY REPORT (B)(4), THE PATIENT HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACED ON (B)(6) 2020. THREE T FASTENERS WERE PLACED TO ANCHOR THE GASTRIC WALL AGAINST THE INTRA-ABDOMINAL WALL. AN 18FR GASTROSTOMY TUBE (G TUBE) WAS PLACED AND THE RETENTION BALLOON FILLED WITH 10CC SALINE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020. THE PATIENT WOKE UP ON (B)(6) 2020 WITH LEFT LOWER QUADRANT ABDOMINAL PAIN. FLUSHING THE TUBE REDUCED THE PAIN, HOWEVER, AFTER AWAKING FROM A NAP THE PATIENT EXPERIENCED "EXCRUCIATING PAIN" IN THE LEFT ABDOMEN THAT RADIATED UP TO THE LEFT SHOULDER. IN THE EMERGENCY DEPARTMENT, A CT SCAN SHOWED "MALPOSITIONED DISPLACED G-TUBE (EXTRALUMINAL) WITH MILD LOCULATED ABDOMINOPELVIC FLUID AND SEVERAL FOCI OF GAS ADJACENT TO THE STOMACH." THE G TUBE WAS INTACT THROUGH THE ABDOMINAL WALL BUT WAS NO LONGER IN THE STOMACH. THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2020. THE T FASTENERS HAD BEEN REMOVED A COUPLE DAYS PREVIOUS. THE SURGEON REPORTED "A HOLE/PERFORATION OF THE POSTERIOR STOMACH ALONG THE GREATER CURVATURE. THERE WAS ALSO SOME PURULENT FLUID IN THE ABDOMINAL CAVITY." THE BALLOON WAS FOUND TO HAVE ONLY

  Patient problems: Abdominal Pain; Ascites

  MAUDE report 10026729 ↗