AVANOS 98434Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00350770984346), received between Aug 26, 2020 and Aug 14, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50246507 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241191 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238859 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238815 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50238804 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214506 ↗
• MalfunctionAug 11, 2026Break

  It was reported that the suture on the T fastener broke during the procedure. There was no patient injury and no additional medical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214505 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A GASTROSTOMY WAS PERFORMED, WITH THREE SUTURES, ON (B)(6) 2026. ON THE WEEKEND ALL THREE SUTURES BROKE. NO MEDICAL INTERVENTION TAKEN. THE MOTHER HAS BEEN ADVISED TO MONITOR THE FEEDING TUBE AND CONTACT THE DEPARTMENT IF NEEDED. PATIENT IS BEING MONITORED BY A HOME HEALTH NURSE + PHYSICIAN INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068105 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED "DURING DILATION WITH INTRODUCER KIT, ALL 3 SUTURES BROKE... WHILE INSERTING DILATOR WITH A TWISTING MOTION...TRIED TO PLACE MIC G-TUBE 20FR, BUT IT WAS UNSUCCESSFUL...THEN DISCONTINUED THE PROCEDURE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461174 ↗
• InjuryDec 10, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED, "ONE OF THE THREE POINTS COULD NOT BE SECURED. THERE WAS A SUSPICION OF LOCALIZED PERITONITIS, SO IT WAS DECIDED TO PERFORM AN OPEN SURGERY." PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, ¿ONE OF THE THREE GASTROPEXY FIXATION POINTS WAS NOT FIXED. THE SUTURE WAS INTACT (NOT BROKEN). PREOPERATIVE CT CONFIRMED THAT THE T-BAR HAD MIGRATED INTO THE ABDOMINAL CAVITY. AN X-RAY WAS ALSO TAKEN THE DAY BEFORE SURGERY. PARTIAL FEEDING (HALF DOSE) HAD ALREADY STARTED ON MONDAY. LOCALIZED PERITONITIS WAS SUSPECTED BASED ON THE PATIENT¿S ABDOMINAL PAIN. THE PHYSICIAN JUDGED THAT THE CONDITION HAD NOT PROGRESSED TO GENERALIZED PERITONITIS. POSTOPERATIVE COURSE HAS BEEN STABLE, WITH A BUMPER IN PLACE. SENIOR PHYSICIAN NOTED THAT POSTOPERATIVE THICKENING OF THE GASTRIC OMENTUM (DUE TO PREVIOUS CANCER SURGERY) MAY HAVE CONTRIBUTED TO DIFFICULTY INSERTING THE PUNCTURE NEEDLE OR FULLY DEPLOYING THE T-BAR, LEADING TO INCOMPLETE FIXATION.¿

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 23769168 ↗
• MalfunctionOct 29, 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 9611594-2025-00253 FOR THE SECOND EVENT. IT WAS REPORTED THAT AN ENDOSCOPIC GASTROSTOMY WAS PERFORMED ON (B)(6). THREE ANCHOR BLOCKS PLACED FOR GASTROPEXY (BLOCKS TO BE REMOVED ON DAY-15 AFTER SURGERY). THE OTHER TWO 'BLOCKS' FELL OUT ON DAY-3." THE DEVICE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416792 ↗
• MalfunctionOct 29, 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 9611594-2025-00254 FOR THE SECOND EVENT. IT WAS REPORTED THAT AN ENDOSCOPIC GASTROSTOMY WAS PERFORMED ON (B)(6). THREE ANCHOR BLOCKS PLACED FOR GASTROPEXY (BLOCKS TO BE REMOVED ON DAY-15 AFTER SURGERY). "ONE BLOCK FELL OUT ON DAY-1 WHEN THE DRESSING WAS CHANGED." THE DEVICE HAS BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416790 ↗
• MalfunctionOct 3, 2025Migration; Migration

  IT WAS REPORTED THAT THE SUTURES BROKE 48-HOURS AFTER INSERTION. "NO INCIDENTS DURING INSERTION, SIMPLE PROCEDURE. EXPERIENCED PROFESSIONAL, FAMILIAR EQUIPMENT. ON (B)(6) 2025 A 3-STAGE COMPUTED TOMOGRAPHY (CT) WITH INTRAVENOUS (IV) WAS PERFORMED AND IT NOTED: -AT THE ABDOMINOPELVIC LEVEL: GASTROSTOMY TUBE IN INTRAGASTRIC POSITION. -TUBES REMOVED WITH DISTAL METAL PART IN INTRAGASTRIC POSITION ON A DEPENDENT SLOPE. -NO ABSCESS OR BLEEDING LESION IDENTIFIED TODAY. -NO FOCAL PARIETAL THICKENING OF THE DIGESTIVE LOOPS WITHIN THE LIMITS OF THE EXAMINATION. -NON-SPECIFIC PNEUMOPERITONEUM FOLLOWING THE INSERTION OF A GASTROSTOMY TUBE. A SMALL AMOUNT. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR THE PATIENT'S CARE INCLUDED "PATIENT MONITORING STRENGTHENED."

  Patient problems: Foreign Body In Patient

  MAUDE report 23211193 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THE "STERILE INFLATION OF THE STOMACH AND ANCHORING OF THE ANTERIOR WALL OF THE STOMACH TO THE ANTERIOR WALL OF THE ABDOMEN UNDER FLUOROSCOPIC CONTROL" WAS PERFORMED. THERE WAS A "GASTRIC PUNCTURE AND DILATATION OF THE PUNCTURE TRACT ON A METAL GUIDE WIRE. THE ANCHORS FELL OUT WHEN THE PRELIMINARY INTRODUCER WAS INSERTED." THIS WAS "PLACEMENT OF A 20F GASTROSTOMY TUBE. THE BALLOON [WAS] INFLATED WITH 10 CC OF SALINE." WALL THICKNESS WAS 3 CM." THIS WAS NOTED TO BE A SIMPLE PROCEDURE." THE PATIENT IS REPORTED TO BE STABLE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815110 ↗
• MalfunctionAug 7, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED, "BAR HAD PENETRATED THE GASTRIC WALL AND WAS LOCATED WITHIN THE ABDOMINAL MUSCLE LAYER. SURGICAL REMOVAL UNDER LOCAL ANESTHESIA IS SCHEDULED AT A LATER DATE. THE GASTROSTOMY OPERATION WAS PERFORMED ON JUNE 20. ON JULY 9, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF A STINGING PAIN AT THE INSERTION SITE, AND AN INFECTION WAS CONFIRMED AT ONE OF THE GASTRIC FIXATION POINTS."

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22744158 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED, "IN THE INTERVENTIONAL RADIOLOGY ROOM FOR A GASTROSTOMY TUBE INSERTION: WHEN THE RADIOLOGIST PUSHED THE INTRODUCER, THE WIRE OF THE 2 ANCHORS BROKE (CUT AT THE WIRE-ANCHOR HEAD JUNCTION). THE OTHER 2 UNUSED ANCHORS IN THE KIT ALSO APPEAR TO BE WEAK". PER ADDITIONAL INFORMATION RECEIVED ON 17MAY2025, ¿THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITH INCREASED VIGILANCE REQUIRED OF THE DEPARTMENT AFTER THE INTERVENTION.¿ THERE WAS NO NEED FOR A SECOND INTERVENTION. THE PATIENT DIED OF RESPIRATORY DISTRESS. PER ADDITIONAL INFORMATION RECEIVED ON 6JUN2025, "THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE GASTROSTOMY PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285447 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED DURING GASTROSTOMY TUBE (GJ) PLACEMENT VIA ENDOSCOPY THE PHYSICIAN REPORTED UNCOILING OF THE GUIDEWIRE. "PHYSICIAN ALSO REPORT[ED] THE DISTAL TIP OF THE TELESCOPING DILATOR POPPED OFF." THE GJ TUBE PLACEMENT WAS ABORTED AND A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PLACED INSTEAD. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 15-OCT-2024 NOTED "THE DILATOR BROKE INSIDE OF THE PATIENT, NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED."

  Patient problems: Foreign Body In Patient

  MAUDE report 20591882 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT ONE SAFETY-PEXY BROKE ON THE DAY OF PLACEMENT, (B)(6) 2022, AND THE OTHER TWO REMAINED. THE NEXT DAY, AN X-RAY WAS PERFORMED TO VERIFY PLACEMENT AND FOUND THAT THE REMAINING TWO SAFETY-PEXIES WERE NOT PRESENT. X-RAY VISUALIZED ONE T-BAR FLOATING IN THE STOMACH. THE PHYSICIAN WAS GOING TO SEND THE PATIENT FOR A BOWEL WASH. THE PATIENT IS HOSPITALIZED AND FED VIA A NASOGASTRIC TUBE.

  Patient problems: Insufficient Information

  MAUDE report 15307473 ↗
• MalfunctionApr 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE FOUR SUTURES FAILED AFTER PLACEMENT. THE PATIENT WAS REQUIRED TO UNDERGO ANOTHER PLACEMENT PROCEDURE THE FOLLOWING DAY. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103003 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH/ FDA USER FACILITY REPORT #MW5106276 THE FOLLOWING: PEG TUBE BEING PLACE AND DILATOR SHEATH SEPARATED ON REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12911722 ↗
• MalfunctionAug 6, 2021Malposition of Device; Premature Separation; Malposition of Device; Premature Separation

  IT WAS REPORTED TO THE SALES REPRESENTATIVE THAT ONE OF THE SAF-T-PEXY SUTURES IN THE KIT DEPLOYED PREMATURELY. THE FIRST ONE USED DEPLOYED PERFECTLY, HOWEVER, THE SECOND SUTURE'S BLUE 'LOCKING' MECHANISM WAS NOT MOVED AND THE INNER CYLINDER WAS NOT YET PUSHED INTO THE OUTER CYLINDER, AND YET THE SAF-T-PEXY SUTURE DEPLOYED INTO THE PATIENT'S PERITONEUM LINING. THE DOCTOR WAS UNABLE TO REMOVE IT. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AFTER THE REPORTED INCIDENT, AS THE SURGEON FELT THE PATIENT'S ANATOMY WAS NOT SUITED FOR A FEEDING TUBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12288504 ↗
• MalfunctionJun 4, 2021Material Separation; Material Separation

  IT WAS REPORTED VIA THE DISTRIBUTOR THAT DURING THE PROCEDURE, ONCE THE PEEL AWAY SHEATH WAS LEFT AND AFTER THE DILATOR WAS REMOVED, THE DOCTOR DISCOVERED THAT A PIECE OF THE DILATOR WAS INSIDE THE PATIENT, ON THE STOMACH. THE PIECE WAS REMOVED VIA ENDOSCOPE. THE PATIENT WAS DESCRIBED ONLY AS "AN ADULT." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 11942712 ↗
• MalfunctionAug 26, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DILATOR BROKE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT USING JAW FORCEPS, AND THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 7 AUG 2020, THE DISTAL END OF THE DILATOR HAD BROKEN, LEAVING A 1.5 INCH SECTION IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE BROKEN DILATOR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10453673 ↗