AVANOS 98430Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00350770984308), received between May 1, 2020 and May 19, 2026 — classified as 1 death, 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Device Appears to Trigger Rejection

  IT WAS REPORTED THAT PATIENT HAD A GASTROPEXY METAL BAR THAT HAD COME THROUGH HER SKIN AT THE STOMA SITE. THE PATIENT WAS EXPERIENCING OOZING FROM STOMA SITE. SHE WAS SEEN BY HER DOCTOR AND STARTED ON ANTIBIOTICS. THE MIC TUBE IS WORKING NORMALLY AND THE PATIENT DENIES PAIN OR ANY OTHER COMPLAINTS.

  Patient problems: Local Reaction; Perforation

  MAUDE report 25218698 ↗
• MalfunctionNov 26, 2025Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 25-NOV-2025 STATING: "PART OF ONE OF THE T- FASTENER ENDS HAS NOW BEEN EXTRUDED VIA THE PATIENT¿S GASTRO-CUTANEOUS FISTULA."

  Patient problems: Abdominal Distention; Cough; Fever; Peritonitis; Unspecified Infection; Vomiting

  MAUDE report 23661045 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED "SAF T-PLEXY SUTURES FAILED DURING PLACEMENT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729142 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED, "DURING THE PROCEDURE OF PLACING A GASTROSTOMY TUBE BY PERCUTANEOUS TECHNIQUE WITH MIK INTRODUCER KIT, THERE WAS A PROBLEM WITH THE DILATION SYSTEM. THE INTERNAL DILATORS GOT STUCK IN THE PEEL AWAY SHEATH. TRYING TO PULL THE SYSTEM OUT TO LEAVE THE SHEATH PEEL AWAY, THE TIP OF THE TELESCOPIC SYSTEM DETACHED AND REMAINED IN THE PATIENT'S STOMACH... IT WAS NOT POSSIBLE TO TAKE A PICTURE OF THE DILATORS EMBEDDED IN THE OUTER SHEATH BECAUSE, IN ORDER TO VERIFY THEIR PRESENCE, THE SHEATH WAS PEELED AWAY, ON THE SURGICAL TABLE. THE GASTROSTOMY TUBE WAS PLACED DUE TO THE PRESENCE OF THE GUIDE WIRE STILL IN PLACE." ADDITIONAL INFORMATION RECEIVED 17-APR-2025 STATING, "THE TIP HAS NOT BEEN RETRIEVED. AT PRESENT, PHYSICIANS HAVE DECIDED TO WAIT FOR THE TIP TO BE NATURALLY EJECTED. AT THE MOMENT THERE HAS BEEN NO INJURY TO OUR KNOWLEDGE".

  Patient problems: Foreign Body In Patient

  MAUDE report 22032016 ↗
• MalfunctionJun 19, 2024Break; Break

  PER ADDITIONAL INFORMATION RECEIVED ON 27AUG2024, ¿THE WHITE DISCS ON THE GASTROPEXIES CAME OFF. THE TUBE PLACED WAS OUR STANDARD 12FRENCH MIC TUBE. I BELIEVE THE PATIENT DID DEVELOP PERITONITIS AFTER THE PROCEDURE. THIS WAS AN UNEXPECTED EVENT AND NOT DIRECTLY RELATED TO ANOTHER ONGOING HEALTH ISSUE."

  Patient problems: Insufficient Information; Peritonitis

  MAUDE report 19567290 ↗
• DeathJun 19, 2024Break; Malposition of Device; Unintended Movement; Break; Malposition of Device; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2024-00109 FOR THE FIRST REPORT. IT WAS REPORTED, "LAST WEEK WE HAD AN ISSUE WITH SOME OF THE GASTROPEXIES USED ON A PATIENT. THE DAY AFTER RIG INSERTION AT LEAST TWO OF THE GASTROPEXIES SNAPPED OFF (THREE HAD BEEN INSERTED DURING PROCEDURE).¿ PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 , RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) WAS INSERTED ON (B)(6) 2024 AND PATIENT UNFORTUNATELY PASSED AWAY ON (B)(6) 2024. ¿THE DEATH WAS LIKELY IN SOME WAY RELATED TO THE GASTROPEXIES. AS THE GASTROPEXIES HAD FALLEN OUT VERY SOON AFTER THE PROCEDURE, PATIENT HAD ONGOING ISSUES WITH LOOSE RIG AS THE TRACT WASN¿T STABLE. THE BALLOON MIGRATED OUT OF THE STOMACH AND INTO THE PERITONEUM LIKELY CONTRIBUTING TO PATIENT DEATH.¿

  Patient problems: Insufficient Information; Peritonitis

  MAUDE report 19567288 ↗
• MalfunctionJan 9, 2023Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2023-00002 FOR THE SECOND REPORT. REFER TO 9611594-2023-00003 FOR THE THIRD REPORT. REFER TO 9611594-2023-00004 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE SUTURES FAILED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16127466 ↗
• MalfunctionJan 9, 2023Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2023-00001 FOR THE FIRST REPORT. REFER TO 9611594-2023-00002 FOR THE SECOND REPORT. REFER TO 9611594-2023-00003 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUTURES FAILED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16127458 ↗
• MalfunctionJan 9, 2023Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2023-00001 FOR THE FIRST REPORT. REFER TO 9611594-2023-00002 FOR THE SECOND REPORT. REFER TO 9611594-2023-00004 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE SUTURES FAILED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16127455 ↗
• MalfunctionJan 9, 2023Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2023-00001 FOR THE FIRST REPORT. REFER TO 9611594-2023-00003 FOR THE THIRD REPORT. REFER TO 9611594-2023-00004 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE SUTURES FAILED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16127451 ↗
• MalfunctionSep 29, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2022-00122 FOR THE FIRST REPORT. REFER TO 9611594-2022-00123 FOR THE SECOND REPORT. IT WAS REPORTED, THE SITE HAD A PATIENT THAT EXPERIENCED EMBEDDED BUTTON(S) AT AROUND THE 4- WEEK MARK; AND REQUIRED THE BUTTON(S) BE REMOVED VIA A SURGICAL PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15508354 ↗
• MalfunctionSep 29, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2022-00123 FOR THE SECOND REPORT. REFER TO 9611594-2022-00124 FOR THE THIRD REPORT. IT WAS REPORTED, THE SITE HAD A PATIENT THAT EXPERIENCED EMBEDDED BUTTON(S) AT AROUND THE 4- WEEK MARK; THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15508343 ↗
• MalfunctionSep 29, 2022Unintended Movement; Unintended Movement

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2022-00122 FOR THE FIRST REPORT. REFER TO 9611594-2022-00124 FOR THE THIRD REPORT. IT WAS REPORTED, THE SITE HAD A PATIENT THAT EXPERIENCED EMBEDDED BUTTON(S) AT AROUND THE 4- WEEK MARK; THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15508256 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PARENTS HAD CALLED [THE HOSPITAL], THAT THE CHILD¿S PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] AREA WAS TENDER, THE PHYSICIAN HAD SCHEDULED AN APPOINTMENT FOR FRIDAY THE SAME WEEK. ON (B)(6) 2021 A PAEDIATRIC SURGEON PLACED A MIC-KEY ENTERAL FEEDING TUBE INTO THE PATIENT USING THE INTRODUCER KIT-TECHNIQUE. BESIDES THE PEDIATRIC SURGEON, A PEDIATRICIAN HAD BEEN PRESENT AT THE ENDOSCOPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021 THE FAMILY MEMBERS HAD CALLED THE HOSPITAL, THE CHILD¿S PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] AREA WAS TENDER, THE PHYSICIAN HAD SCHEDULED AN APPOINTMENT FOR FRIDAY THE SAME WEEK. ON (B)(6) 2021 THE PATIENT HAD BEEN BROUGHT TO THE EMERGENCY ROOM DUE TO TENDERNESS, REDNESS AND PAIN IN THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] AREA. ULTRASOUND OF THE ABDOMEN HAD BEEN PERFORMED. ON (B)(6) 2021, GRANULOMA [HAD BEEN OBSERVED] IN THE AREA OF THE FEEDING PORT (MIC-KEY), AS WELL AS AN ABSCESS AT THE ROOT OF THE GASTROPEXY (AT THE ROOT OF THE ANCHOR BUTTON). ABSCESS HAD BEEN PUNCTURED AND CLEANED. DURING THIS TIME, THE GASTROPEXY BUTTONS HAD FALLEN OUT AT THE RIGHT TIME (WHICH IS USUALLY APPROXIMATELY 3 WEEKS FOR CHILDREN). R

  Patient problems: Skin Discoloration; Skin Disorders; Skin Inflammation/ Irritation

  MAUDE report 14569225 ↗
• MalfunctionMay 13, 2022Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED AN INTRODUCER PLACEMENT KIT (IPK) TO MICKEY-G PROCEDURE; IT WAS ENDOSCOPICALLY MONITORED. AFTER THE SERIAL DILATOR WAS REMOVED AND THE TUBE WAS PLACED THE PHYSICIAN NOTED, WHILE REMOVING THE GUIDEWIRE, THAT A SMALL WHITE PLASTIC PIECE WAS STUCK ON THE GUIDEWIRE AT THE BASE OF THE G-TUBE; IT WAS THE TIP OF THE DILATOR, WHICH HAD SNAPPED OFF INSIDE OF THE PATIENT. THE PHYSICIAN STATED THAT IT WAS SMALL ENOUGH TO PASS THROUGH [THE PATIENT¿S INTESTINES]. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PASSING OF THE TIP OF THE DILATOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 14402516 ↗
• MalfunctionApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE "PATIENT INFORMED OF AN OLD GASTROPEXY SITE (UPPER LEFT) THAT NEVER HEALED PROPERLY AND HE NOTICED PUS COMING FROM THE SITE AND HE SQUEEZED THE PIN PRICK HOLE 6 WEEKS AGO AND THEN A STAINLESS STEEL PIN CAME OUT MEASURING 1MM IN DIAMETER AND 10.5MM LONG. UNFORTUNATELY HE LOST THE PIN WHEN VISITING THE DIETICIANS AS HE WAS GOING TO SHOW THEM. HE IS VERY CONCERNED THAT THIS WAS LEFT IN HIS BODY AND THE TEAM DOING THE TUBE INSERTION PROCEDURE SHOULD BE INFORMED SO THIS DOESN¿T HAPPEN AGAIN. THE OLD GASTROPEXY SITE HAS NOW HEALED.

  Patient problems: Foreign Body In Patient; Purulent Discharge

  MAUDE report 14141997 ↗
• MalfunctionDec 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE GASTROPEXY SUTURES BROKE WITHIN TWO HOURS OF PLACING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11091390 ↗
• MalfunctionDec 29, 2020Entrapment of Device; Migration; Entrapment of Device; Migration

  IT WAS REPORTED THAT THE GASTROSTOMY BUTTON WAS PLACED WITH THE ASSISTANCE OF THE INTRODUCER KIT IN 2014, AT BIRTH OF CHILD. IN 2019, TWO OF THE THREE SAF-T-PEXY ANCHORS WERE STILL IN PLACE IN THE MUCOSA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11091322 ↗
• MalfunctionNov 25, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2020-00234 FOR THE FIRST REPORT. IT WAS REPORTED THAT ONE OF THE THREE GASTROPEXY SUTURES "FELL OFF" ON POST-OPERATIVE DAY FOUR. BY POST-OPERATIVE DAY NINE, A SECOND SUTURE "CAME AWAY." THE THIRD SUTURE REMAINED IN SITU ON POST-OPERATIVE DAY 14 "WITH NIL CONCERNS." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 13-NOV-2020 INDICATED THE DEVICE WAS REPLACED WITH A MIC G-TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900447 ↗
• MalfunctionNov 25, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2020-00237 FOR THE SECOND REPORT. IT WAS REPORTED THAT ONE OF THE THREE GASTROPEXY SUTURES "FELL OFF" ON POST-OPERATIVE DAY FOUR. BY POST-OPERATIVE DAY NINE, A SECOND SUTURE "CAME AWAY." THE THIRD SUTURE REMAINED IN SITU ON POST-OPERATIVE DAY 14 "WITH NIL CONCERNS." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 13-NOV-2020 INDICATED THE DEVICE WAS REPLACED WITH A MIC G-TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900334 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT TWO OF THE THREE GASTROPEXY SUTURES HAD FALLEN OFF BY DAY FOUR POST-INSERTION. DAY 1 POST REVIEW, ABDOMINAL DISTENTION WAS NOTED. THE FINAL SUTURE FELL OUT BY DAY 8. ADDITIONAL INFORMATION RECEIVED 2020-07-27 INDICATED THERE WAS NO PATIENT INJURY AND NO NEED FOR MEDICAL INTERVENTION OR TREATMENT. PATIENT'S CURRENT CONDITION WAS LISTED AS "NO CONCERNS, FUNCTIONAL RIG [RADIOLOGICALLY INSERTED GASTROSTOMY] TUBE."

  Patient problems: Abdominal Distention

  MAUDE report 10399033 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT THREE GASTROPEXY SUTURES WERE INSERTED AT TIME OF INITIAL INSERTION. ONE SUTURE (3 O'CLOCK POSITION) HAD FALLEN OFF BY DAY 3 POST-INSERTION. ON DAY 13 POST-INSERTION, ONE OF THREE SUTURES REMAINED (9 O'CLOCK POSITION SUTURE WAS NOT PRESENT). ADDITIONAL INFORMATION RECEIVED 03-AUG-2020 INDICATED THERE WAS NO PATIENT INJURY AND NO NEED FOR MEDICAL INTERVENTION; THE PATIENT WAS OBSERVED. THE PATIENT'S CONDITION WAS REPORTED AS "PATIENT WELL WHEN THE REPORTING FORM WAS WRITTEN." ACCORDING TO THE DISTRIBUTOR, NO OBVIOUS SIGNS OF A MANUFACTURING RELATED ISSUE WERE IDENTIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10399012 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT'S GASTROSTOMY TUBE WAS PLACED (B)(6) 2020. TWO OF THE GASTROPEXY SUTURES HAD FALLEN OFF BY DAY 10 POST INSERTION. DAY 1 POST REVIEW, IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN. CT SCAN COMPLETED AND NOTED "VERY SMALL SELF-LIMITING LEFT RECTUS SHEATH HAEMATOMA WHICH WILL BE CAUSING SOME OF THE PAIN AT LEAST." IT WAS ADVISED TO DELAY THE FIRST BALLOON WATER CHANGE BY ONE WEEK. ADDITIONAL INFORMATION RECEIVED 28-JUL-2020 INDICATED THERE WAS NO INJURY AND NO NEED FOR MEDICAL INTERVENTION OR TREATMENT. THE PATIENT'S CONDITION IS "NO CONCERNS, FUNCTION RIG [RADIOLOGICALLY INSERTED GASTROSTOMY] TUBE.

  Patient problems: Hematoma; Pain

  MAUDE report 10392274 ↗
• MalfunctionJul 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT ALL SUTURES CAME OFF ON DAY 3 POST PLACEMENT. IT WAS ADVISED TO DELAY THE WATER CHANGE IN THE BALLOON (OF ASSOCIATED 8110-12LV MIC* BOLUS GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTOR) BY ONE WEEK, AND ALSO TO ADD AN ADDITIONAL 1ML WATER TO THE BALLOON. AN ADDITIONAL 1 ML OF WATER WAS ADDED ON (B)(6) 2020. THERE HAD ALSO BEEN A SMALL AMOUNT OF BLEEDING AT THE SITE. THE BLEEDING HAD IMPROVED BY THE DISCHARGE DATE. ON FOLLOW UPS WITH THE COMMUNITY NURSE ON (B)(6) 2020, LEAKAGE AROUND THE STOMA SITE WAS NOTED. ON (B)(6) 2020, A CT SCAN WAS PERFORMED ON THE PATIENT AT A&E WHICH SHOWED THAT THE TUBE HAD BECOME DISPLACED. THE TUBE WAS REMOVED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292765 ↗
• MalfunctionJun 8, 2020Fracture; Fracture

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2020-00093 FOR THE FIRST REPORT, REFER TO 9611594-2020-00094 FOR THE SECOND REPORT. IT WAS REPORTED BY THE HOSPITAL VIA THE DISTRIBUTOR THAT THE SUTURES FAILED WITHIN 48 HOURS OF PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED 2 JUN 2020, THE PATIENT IS STABLE, AND NO FOLLOW UP WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128614 ↗