AVANOS 98432Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00350770984322), received between Oct 7, 2019 and Sep 17, 2026 — classified as 5 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (49 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 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Premature Separation

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50809552 ↗
• MalfunctionMay 26, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00354 FOR THE SECOND REPORT. IT WAS REPORTED THAT SUTURES OF AN INITIAL PLACEMENT KIT BROKE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS OBSERVED OVERNIGHT PER STANDARD PROTOCOL. HE IS NOW DISCHARGED UNDER USUAL CARE TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279073 ↗
• MalfunctionApr 10, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE DEVICE WAS IMPLANTED, THE NURSES NOTICED THAT TWO OF THE THREE ANCHORS HAD FALLEN ONTO THE PATIENT¿S BED AND THAT THE THIRD HAD COME LOOSE. THE PATIENT UNDERWENT ANOTHER PROCEDURE IN THE OPERATING ROOM THAT SAME DAY TO REPLACE ALL THREE ANCHORS. REPLACEMENT WITHOUT INCIDENTS. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840904 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THE "GUIDEWIRE WAS KINKED AT THE TIP STRAIGHT OUT OF PACKAGE ANCHOR SUTURES BROKE [TWO TIMES] WHILE TRYING TO ADVANCE THE SHEATH IN STOMACH. DIFFICULT TO ADVANCE G-TUBE THROUGH THE PEEL AWAY IT PULLED THE TUBE BACK OUT OF THE STOMACH DESPITE TUBE BEING ADEQUATELY LUBRICATED AND FIXED IN PLACE MANUALLY." ANOTHER DEVICE WAS OPENED AND USED. THE PATIENT WAS REPORTED TO BE IN RECOVERY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715455 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED, ¿ON (B)(6), 2026, DURING A GASTROSTOMY PROCEDURE ON A 77-YEAR-OLD PATIENT, IT WAS NOTICED WHEN PLACING THE ANCHORS THAT THE THREADS WERE BREAKING (TWO OUT OF FOUR), MAKING THE PROCEDURE IMPOSSIBLE. AN IDENTICAL REFERENCE KIT FROM AN UNKNOWN BATCH WAS USED AS A REPLACEMENT. THIS INCIDENT HAD NO CLINICAL CONSEQUENCES FOR THE PATIENT.¿ PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026, THE SUTURE BREAK OCCURRED DURING PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681630 ↗
• MalfunctionDec 17, 2025Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED, ¿WHILE CHANGING THE 58-YEAR-OLD PATIENT HOSPITALIZED FOR ISCHEMIC STROKE, THE GASTROSTOMY TUBE (INSERTED ON (B)(6) 2025) WAS FOUND IN THE BED, HAVING FALLEN SPONTANEOUSLY FROM THE GASTRIC OPENING (NO SENSATION OF TEARING DURING CARE). THE NURSE NOTICED THAT THE BALLOON THAT HOLDS THE TUBE IN PLACE WAS NO LONGER THERE AND APPEARED TO HAVE BURST. INSERTION OF A NASOGASTRIC TUBE FOLLOWED BY A NEW PERCUTANEOUS GASTROSTOMY TUBE ON THE SAME DAY IN THE INTERVENTIONAL RADIOLOGY UNIT."

  Patient problems: Insufficient Information

  MAUDE report 23827794 ↗
• MalfunctionDec 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED, ¿DURING A GASTROSTOMY PROCEDURE, THE ANCHOR CAME LOOSE IN THE PATIENT." PER ADDITIONAL INFORMATION RECEIVED ON 28NOV2025, A NEW KIT WAS OPENED AND THE PROCEDURE WAS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 23827785 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED, "DEFECTIVE GASTROSTOMY KIT ANCHORS. SEVERAL DEVICES ARE AFFECTED. THE THREAD FOR ATTACHING THE ANCHOR BREAKS."

  Patient problems: Insufficient Information

  MAUDE report 23761486 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED, "GASTROSTOMY ANCHOR PROBLEM: FELL OUT PREMATURELY."

  Patient problems: Insufficient Information

  MAUDE report 23704991 ↗
• InjuryNov 12, 2025Break; Break

  IT WAS REPORTED THERE WAS A "PREMATURE RUPTURE OF THE PEXIE WIRES OCCURRED THE DAY AFTER GPR [PERCUTANEOUS RADIOLOGIC GASTROSTOMY] PLACEMENT, PERFORMED ON (B)(6) 2025 (WITH LOSS OF ALL 3 STUDS). THE CLINICAL CONSEQUENCE WAS A WALL ABSCESS REQUIRING NOSOCOMIAL ANTIBIOTIC THERAPY. THE PROBE HAD TO BE REMOVED PENDING HEALING OF THE INFECTION BEFORE REINSERTION."

  Patient problems: Abscess; Bacterial Infection

  MAUDE report 23534860 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THERE WAS AN ISSUE WITH "20FR SERIAL DILATOR WITH A PEEL-AWAY SHEATH. THE DILATORS WOULD NOT DEPLOY. IT ENDED UP BENDING AND GETTING STUCK IN THE PATIENT." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23503627 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT TWO SUTURES PINS BROKE THE DAY AFTER PLACEMENT. THE TWO PINS THAT FELL OUT AND WERE NOT RETAINED. THE NEXT DAY THERE WAS A REOPERATION TO REPLACE THEM. THE PATIENT'S CURRENT CONDITION IS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328449 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THERE WAS "SPONTANEOUS BREAKAGE OF THE ANCHOR WIRE ON TWO ANCHORS DURING THE PROCEDURE." AN ADDITIONAL MEDICAL DEVICE OPENED. NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23068940 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT THE SUTURES OF AN IPK [INITIAL PLACEMENT KIT] BROKE WITHIN TWO WEEKS AFTER PLACEMENT. NO INJURIES REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015160 ↗
• MalfunctionAug 28, 2025Break; Break

  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 9611594-2025-00191 FOR THE SECOND EVENT. IT WAS REPORTED THE SUTURE "ANCHOR WIRES ARE BREAKING." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 05-AUG-2025 STATED NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913342 ↗
• MalfunctionAug 28, 2025Break; Break

  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 9611594-2025-00190 FOR THE FIRST EVENT. IT WAS REPORTED THE SUTURE ANCHOR HAVE "DROPPED." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 05-AUG-2025 STATED NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913336 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED, "UNDER GASTROSCOPIC GUIDANCE, "ANCHORS" ATTACHED TO SUTURE MATERIAL ARE INSERTED INTO THE STOMACH VIA AN INCISION IN THE SKIN. THE ANCHORS ARE TIGHTENED AND FIXED EXTERNALLY USING PLASTIC BUTTONS WITH A BUILT-IN CLAMP. UNFORTUNATELY, THIS CLAMP CUTS THE THREADS. CONSEQUENTLY, THE ANCHORS ARE OUT OF FUNCTION AND THE INTENDED TIGHTENING OF THE STOMACH AGAINST THE INNER SIDE OF THE ABDOMINAL WALL DOES NOT OCCUR. THIS IS ONLY VISUALIZED AFTER THE PROBE (THE PURPOSE OF THE PROCEDURE) HAS BEEN INSERTED INTO THE STOMACH. THEREFORE, THE PROBE LIES LOOSELY IN THE CAVITY OF THE ORGAN WITH THE RISK OF DISPLACEMENT INTO THE ABDOMINAL CAVITY.¿

  Patient problems: Insufficient Information

  MAUDE report 22579331 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED, "WE HAD TO INSERT A PEG TUBE. WHEN PLACING THE THREE ANCHORS, THE FIRST ANCHOR SELF-RELEASED, WHICH IS WHY WE DID NOT USE THE REMAINING 3 PIECES IN THE PACKAGE, BUT OPENED UP SOME NEW ANCHORS, WHICH WORKED WITHOUT PROBLEMS.¿.

  Patient problems: Insufficient Information

  MAUDE report 22563866 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED, "EXPERIENCED DOCTOR WITH THE AVANOS INTRODUCER KIT HAD PROBLEMS IN THE LAST INTERVENTION WITH THE PEXIAS. GASTROSTOMY TUBE PLACED WITH THE INTRODUCER KIT ON (B)(6). ON (B)(6), THE PEXIAS WERE NOT IN PLACE BUT THE TUBE WAS CORRECTLY PLACED WITHOUT INFLAMMATION SIGNS IN THE INSERTION PLACE.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22563862 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED, "DURING PLACEMENT OF A PUSH PERCUTANEOUS GASTROSTOMY: PLACEMENT OF AN ANCHOR THAT DIDN'T HOLD BECAUSE WHEN CLOSING THE WASHER, THE WIRE BROKE. PLACEMENT OF ANOTHER ANCHOR A FEW CENTIMETRES AWAY. INSTALLATION OF THE 3RD ANCHOR, WHICH ALSO BROKE OFF AT SKIN LEVEL. A TOTAL OF 2 FAULTY ANCHORS, USING A SECOND KIT." THE PROCEDURE WAS COMPLETED WITH ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563858 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED, "EXPERIENCED DOCTOR WITH THE AVANOS INTRODUCER KIT HAS HAD PROBLEMS IN THE LAST INTERVENTION WHEN CLOSING THE SUTURE LOCK BECAUSE THE BIOSYN SUTURE BROKE'S IN THE 4 NEEDLES.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22533217 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED, ¿ON (B)(6) 2025, 2 TO 4 DAYS AFTER A GASTROSTOMY BUTTON HAD BEEN PLACED, 2 FIXATION ANCHORS DETACHED WITHOUT EXPLANATION. THE CHILD WAS TAKEN BACK TO THE OR [OPERATING ROOM] ON (B)(6) 2025 UNDER GENERAL ANAESTHETIC TO REPLACE THE FAULTY GASTROSTOMY BUTTON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22372686 ↗
• MalfunctionJun 20, 2025Separation Problem; Separation Problem

  IT WAS REPORTED "THE SERIAL DILATOR PARTS FELL INSIDE OF THE PATIENT¿S STOMACH RATHER THAN PULLING ALL THE WAY OUT...THE PART THAT GETS PULLED OUT PRIOR TO PUSHING THE TUBE IN, FELL INTO THE STOMACH RATHER THAN BEING ABLE TO BE PULLED OUT." THE HEALTHCARE PROVIDER "ENDED UP RETRIEVING THE LEFTOVER PIECE ENDOSCOPICALLY." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22297285 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED, "ON (B)(6) 2025, A CHILD UNDERWENT A GPE INSERTION WITH AN INTRODUCTION KIT. SHE RETURNED TO THE WARD ON (B)(6) 2025 BECAUSE TWO ANCHORS HAD BECOME DETACHED AFTER HER RETURN HOME. AS THE ANCHORS HAD TO REMAIN IN PLACE FOR AT LEAST TEN DAYS, SHE WAS TAKEN BACK TO THE OPERATING THEATRE THE SAME DAY TO HAVE THREE ANCHORS PUT BACK IN URGENTLY, WITH THE USE OF AN ADDITIONAL GASTROINTESTINAL ANCHORING KIT. THE CLINICAL CONSEQUENCES WERE A SECOND OPERATION UNDER GENERAL ANAESTHETIC TWO DAYS APART. THIS IS A RECURRING INCIDENT IN THE DEPARTMENT." PER ADDITIONAL INFORMATION RECEIVED ON 7MAY2025, A SECOND OPERATION WAS PERFORMED TO REPOSITION THE ANCHORS. THERE WERE NO KNOWN NEGATIVE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100035 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED, ¿THE SERIAL DILATOR BROKE APART DURING A CASE INSIDE A PATIENT. LUCKILY THE CONSULTANT WAS ABLE TO RETRIEVE IT SAFELY AND COMPLETE THE PROCEDURE SUCCESSFULLY.¿ PER ADDITIONAL INFORMATION RECEIVED ON 16APR2025, ¿SERIAL DILATOR INSERTED INTO PEELAWAY SHEATH AND DEPLOYED, AND THEN WHEN DR WENT TO REMOVE SERIAL DILATOR ONLY THE SMALLEST CAME OUT AND OTHER (2 GREY AND 1 RED) WERE STUCK INSIDE THE PEELAWAY SHEATH. SO DOCTOR STARTED TO PEEL AWAY THE SHEATH SO STUCK BITS COULD BE REMOVED WITH FORCEPS ¿ THEN FEEDING TUBE INSERTED AND PEELAWAY SHEATH FULLY REMOVED - SUCCESSFUL OUTCOME.¿

  Patient problems: Insufficient Information

  MAUDE report 21970644 ↗