AVANOS 98431Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00350770984315), received between Sep 4, 2019 and May 19, 2026 — classified as 4 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Break” (78 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2026-00341 FOR THE FIRST REPORT. REFER TO FOR THE SECOND REPORT . REFER TO 9611594-2026-00343 FOR THE THIRD REPORT . IT WAS REPORTED THAT A GASTROSTOMY WAS PERFORMED ON A CHILD AND A SUTURE BROKE AFTER ONE DAY. NO INJURIES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218743 ↗
• MalfunctionMay 19, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2026-00341 FOR THE FIRST REPORT REFER TO 9611594-2026-00342 FOR THE SECOND REPORT REFER TO FOR THE THIRD REPORT . IT WAS REPORTED THAT A GASTROSTOMY WAS PERFORMED ON A CHILD AND TWO SUTURES BROKE AFTER 4 DAYS. NO INJURIES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218732 ↗
• MalfunctionMay 19, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO . FOR THE FIRST REPORT REFER TO 9611594-2026-00342 FOR THE SECOND REPORT REFER TO 9611594-2026-00343 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUTURES COME OFF PREMATURELY. NO INJURIES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218700 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A PREMATURE RUPTURE OF THE PEXIE SUTURES OCCURRED DURING A GPR PROCEDURE WHILE DILATING. THE PHYSICIAN WAS STILL ABLE TO COMPLETE THE PROCEDURE, WITH NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975128 ↗
• MalfunctionMar 5, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00114 FOR THE SECOND REPORT. THE CUSTOMER REPORTED BREAKAGE OF THE SUTURE THREAD ON ONE GASTROPEXY ANCHOR DURING SLIGHT MANUAL TRACTION, ALONG WITH LOOSENING OF A SECOND ANCHOR DURING TRACT DILATION. THE REPORTER ALSO STATED THAT THE GASTROSTOMY TUBE FOLLOWED AN INCORRECT PATHWAY AND EXITED INTRAPERITONEALLY, REQUIRING THE PROCEDURE TO BE REPEATED UNDER A SECOND LOCAL ANESTHETIC WITH INTRAVENOUS PARACETAMOL AND MORPHINE TITRATION DUE TO PAIN ONSET.

  Patient problems: Insufficient Information

  MAUDE report 24521962 ↗
• MalfunctionMar 5, 2026Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00113 FOR THE FIRST REPORT. THE CUSTOMER REPORTED THAT DURING FIRST TRACTION OF A SECOND KIT FROM THE SAME LOT, THE SUTURE THREAD OF ANOTHER ANCHOR BROKE. IN TOTAL, THREE ANCHOR WIRES REMAINED IN THE PATIENT, AND THE GASTROSTOMY WAS STABILIZED USING THREE ANCHORS INSTEAD OF THE INTENDED FOUR.

  Patient problems: Insufficient Information

  MAUDE report 24521960 ↗
• MalfunctionFeb 19, 2026Use of Device Problem

  IT WAS REPORTED THAT A NURSE CUT THE TIP OF HIS FINGER WITH THE #11 SCALPEL INCLUDED IN THE KIT AND REQUIRED STITCHES. THE CUT WAS MINOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24392211 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING USE THE "SECOND GASTROPEXY FAILED TO DEPLOY PROPERLY. IT THEN SUBSEQUENTLY SNAPPED LATER ON IN THE INSERTION AS THE PROVIDER WAS DILATING THE TRACT FOR THE" RADIOLOGICALLY INSERTED GASTROSTOMY (RIG). THERE WAS NO REPORTED INJURY. ADDITIONAL DETAILED INFORMATION RECEIVED 30-SEP-2025 STATED THE PROVIDER "ATTEMPTED TO DEPLOY A SECOND GASTROPEXY CLIP DURING THE PROCEDURE. WHEN [THE PROVIDER] DEPRESSED THE TRIGGER MECHANISM IT DIDN'T PUSH ALL THE WAY IN AND THERE WAS NO CLICK SOUND AND NO METALLIC ANCHOR SEEN TO APPEAR FROM THE TIP OF THE GASTROPEXY. HOWEVER, THE CLIP HAD BEEN DEPLOYED AS [THE PROVIDER] COULDN¿T REMOVE THE WIRE FROM THE PATIENT. ON FURTHER FLUORO IT APPEARED TO BE IN AN APPROPRIATE LOCATION. HOWEVER LATER ON WHEN [THE PROVIDER] WAS DILATING THE TRACT WITH THE PEAL-AWAY SHEATH, THE DEFECTIVELY DEPLOYED GASTROPEXY SNAPPED, SUGGESTING THERE WAS A FURTHER ISSUE WITH THAT GASTROPEXY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316580 ↗
• MalfunctionOct 3, 2025Break; Break

  IT WAS REPORTED THE DILATOR TIP WAS BROKEN. IT REMAINED IN THE PATIENT'S STOMACH. THE CLINICIANS ARE MONITORING THE PATIENT'S CONDITION "FOR NATURAL PASSAGE OF THE FOREIGN OBJECT" IN THE PATIENT'S STOOL. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23211200 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED "DURING THE DRESSING PROCESS" THREE ANCHORS "CAME OFF." ADDITIONAL INFORMATION RECEIVED 30-JUL-2025 STATED "NO MEDICAL INTERVENTION NEEDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913334 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THE GASTROSTOMY TUBE WAS PLACED THROUGH PEEL AWAY SHEATH AND THREE T-FASTENERS BROKE. THE PATIENT IS REPORTED TO BE IN STABLE CON. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579549 ↗
• MalfunctionJul 22, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2025-00169 FOR THE FIRST REPORT. REFER TO 9611594-2025-00170 FOR THE SECOND REPORT. IT WAS REPORTED, EXPERIENCED DOCTOR WITH THE AVANOS INTRODUCER KIT HAD PROBLEMS IN THE LAST INTERVENTION WITH THE T-FASTENERS. GASTROSTOMY TUBE PLACED WITH THE INTRODUCER KIT ON (B)(6) 2025. ON (B)(6) 2025, NONE REMAINED IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 22563867 ↗
• MalfunctionJul 22, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2025-00169 FOR THE FIRST REPORT. REFER TO 9611594-2025-00171 FOR THE THIRD REPORT. IT WAS REPORTED, EXPERIENCED DOCTOR WITH THE AVANOS INTRODUCER KIT HAD PROBLEMS IN THE LAST INTERVENTION WITH THE T-FASTENERS. GASTROSTOMY TUBE PLACED WITH THE INTRODUCER KIT ON (B)(6) 2025. ON (B)(6) 2025, ONLY ONE T-FASTENER REMAINED IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 22563865 ↗
• MalfunctionJul 22, 2025Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2025-00170 FOR THE SECOND REPORT. REFER TO 9611594-2025-00171 FOR THE THIRD REPORT. 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) 2025. ON (B)(6) 2025, ONLY TWO T-FASTENERS REMAINED IN PLACE.

  Patient problems: Insufficient Information

  MAUDE report 22563864 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED, "COELIO-ASSISTED ENDOSCOPE PLACEMENT OF A GPE BUTTON USING THE AVANOS KIT. ONCE THE DILATION IS COMPLETE AND THE BALLOON BUTTON IN PLACE, THE DOCTOR REALIZES THAT ONE OF THE ANCHORS HAS SPONTANEOUSLY DETACHED. FITTING A NEW ANCHOR." NO INJURIES REPORTED, BUT RISK. BROKEN ANCHOR REPLACED. PER ADDITIONAL INFORMATION RECEIVED ON 11JUN2025, "THE CHILD IS DISCHARGED FROM HOSPITAL WITH NO CLINICAL CONSEQUENCES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462622 ↗
• MalfunctionJun 5, 2025Break; Break

  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 9611594-2025-00110 FOR THE FIRST EVENT. REFER TO 9611594-2025-00111 FOR THE SECOND EVENT. IT WAS REPORTED THE "RADIOLOGY PERCUTANEOUS GASTROSTOMY [WAS] PLACED ON (B)(6) 2025: [THREE] FIXATIONS PLACED." ADDITIONAL INFORMATION RECEIVED 16-MAY-2025 NOTED THE CLINICIANS WERE MONITORING THE GASTROSTOMY TUBE PLACEMENT AND NOTED THE LAST FASTENER WENT INTO THE DRESSING THIS MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150655 ↗
• MalfunctionJun 5, 2025Break; Break

  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 9611594-2025-00111 FOR THE SECOND EVENT. REFER TO 9611594-2025-00120 FOR THE THIRD EVENT. IT WAS REPORTED THE "RADIOLOGY PERCUTANEOUS GASTROSTOMY [WAS] PLACED ON 07-MAY-2025: [THREE] FIXATIONS PLACED." [ONE] FIXATION FELL OUT ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150396 ↗
• MalfunctionJun 5, 2025Break; Break

  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 9611594-2025-00110 FOR THE FIRST EVENT. REFER TO 9611594-2025-00120 FOR THE THIRD EVENT. IT WAS REPORTED THE "RADIOLOGY PERCUTANEOUS GASTROSTOMY [WAS] PLACED ON (B)(6)2025: [THREE] FIXATIONS PLACED." [ONE] FIXATION FELL OUT ON (B)(6) 2025. "ONE FIXATION REMAINING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150283 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THE "WIRE FROM TWO ANCHORS BROKEN SO THE DEVICE COULD NOT BE SET. PROCEDURE ABANDONED. PATIENT IN GREAT PAIN AS DEVICE BROKE. INJECTION OF CONTRAST MEDIUM INTO THE PERITONEUM." ADDITIONAL INFORMATION RECEIVED 30-APR-2025 STATED THE PATIENT WAS TREATED WITH 3 MG OF MORPHINE AND FURTHER MANAGEMENT ON BECQUEREL. THERE WAS NO REPORTED INJURY.

  Patient problems: Pain

  MAUDE report 22065712 ↗
• MalfunctionMay 15, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME PATIENT, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00101 FOR THE FIRST EVENT. IT WAS REPORTED FOLLOWING DEVICE PLACEMENT "THE FIXATION STUDS FAILED PREMATURELY", ONE AFTER "48 HOURS, FOLLOWING DETERSION OF THE DRESSING)." IT WAS NOTED THE "BALLOON AND COLLAR WERE CHECKED AND THE USUAL DRESSING APPLIED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032017 ↗
• MalfunctionMay 15, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME PATIENT, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00102 FOR THE SECOND EVENT. IT WAS REPORTED FOLLOWING DEVICE PLACEMENT "THE FIXATION STUDS FAILED PREMATURELY", ONE AFTER 24-HOURS. IT WAS NOTED THE "BALLOON AND COLLAR WERE CHECKED AND THE USUAL DRESSING APPLIED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032015 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED "THE SUTURE THREADS CAME AWAY FROM THE METAL PART OF THE GASTROPEXY SUTURE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032014 ↗
• MalfunctionMar 27, 2025Break; Break

  IT WAS REPORTED, ¿ONE OF THE DISCS FELL OFF ON THE WARD 6 HOURS POSTOPERATIVELY.¿ PER ADDITIONAL INFORMATION RECEIVED ON 03MAR2025, NO INJURY OCCURRED. THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708274 ↗
• MalfunctionMar 11, 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 9611594-2025-00045 FOR THE FIRST EVENT. IT WAS REPORTED AN "THE PATIENT IS THEN AWAKENED. ANOTHER STUD FELL SPONTANEOUSLY IN THE RECOVERY ROOM... NO REOPERATION AFTER BREAKAGE OF 3RD, PATIENT REMAINED WITH 2 STUDS... PATIENT DISCHARGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577168 ↗
• MalfunctionMar 11, 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 9611594-2025-00046 FOR THE SECOND EVENT. IT WAS REPORTED AN "ENDOSCOPIC GASTROSTOMY [WAS PLACED] USING THE POSH. AT THE END OF THE PROCEDURE, 2 PLOTS OUT OF 3 ARE FOUND TO HAVE FAILED, AND ARE REPLACED, PROLONGING THE PROCEDURE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577167 ↗