AVANOS 44643Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00350770446431), received between Sep 22, 2020 and Sep 30, 2026 — classified as 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (17 reports).

14 other recalls cover devices cleared under the same FDA submission (K924065); they may or may not involve this specific model.

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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Remove; Material Too Rigid or Stiff

  It was reported that removal of a gastrostomy tube was difficult because the internal bumper was reportedly too large/rigid. After two unsuccessful removal attempts, a surgeon administered local anesthetic medication to facilitate removal of the gastrostomy tube. The patient experienced significant pain and distress during the removal attempts. No additional injury was reported.

  Patient problems: Distress; Pain

  MAUDE report 50945285 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50844203 ↗
• MalfunctionSep 21, 2026Difficult to Fold, Unfold or Collapse; Difficult to Remove; Material Too Rigid or Stiff

  Patient problems: Discomfort; Pain

  MAUDE report 50844163 ↗
• MalfunctionSep 21, 2026Difficult to Fold, Unfold or Collapse; Difficult to Remove; Material Too Rigid or Stiff

  Patient problems: Discomfort; Pain

  MAUDE report 50844146 ↗
• MalfunctionSep 21, 2026Difficult to Fold, Unfold or Collapse; Difficult to Remove; Material Too Rigid or Stiff

  Patient problems: Discomfort; Pain

  MAUDE report 50844115 ↗
• InjurySep 18, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50820085 ↗
• MalfunctionJun 30, 2026Entrapment of Device

  IT WAS REPORTED THAT WHEN THE PEG WAS TO BE REMOVED, THE BUMPER GOT STUCK IN THE ABDOMEN. THE PATIENT WAS NOT INJURED, BUT AN EMERGENCY GASTROSCOPY¿WITH ITS ASSOCIATED RISKS¿WAS REQUIRED TO REMOVE THE BUMPER. THE PATIENT'S CURRENT STATUS IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668296 ↗
• MalfunctionJun 1, 2026Device Appears to Trigger Rejection; Difficult to Remove

  IT WAS REPORTED A PEG TUBE INTERNAL BUMPER WAS TOO STIFF TO BE REMOVED BY TRACTION, NECESSITATING ENDOSCOPIC REMOVAL. ADDITIONALLY, THE FACILITIES HAVE SEEN AN INCREASE IN STOMA SITE INFECTIONS, WITH NO REPORTED TREATMENT. TRAUMA AND BLEEDING WERE NOTED DURING PLACEMENT. NO SERIOUS INJURY WAS REPORTED. EVENT DATE UNKNOWN.

  Patient problems: Local Reaction

  MAUDE report 25354494 ↗
• MalfunctionNov 3, 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 3006646024-2025-00028 FOR THE FIRST EVENT. IT WAS REPORTED THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) BROKE AT THE CONNECTION BETWEEN THE TUBE AND INTERNAL BOLSTER WHEN THE CLINICIANS USED TRACTION TO REMOVE IT. THE DEVICE WAS INSERTED IN (B)(6). THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453640 ↗
• MalfunctionNov 3, 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 3006646024-2025-00029 FOR THE SECOND EVENT. IT WAS REPORTED THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) BROKE AT THE CONNECTION BETWEEN THE TUBE AND INTERNAL BOLSTER WHEN THE CLINICIANS USED TRACTION TO REMOVE IT. THE DEVICE WAS INSERTED IN FEBRUARY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453450 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED, "DURING [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] PEG PLACEMENT USING THE PULL TECHNIQUE, THE LOOPED PLACEMENT WIRE BROKE WHILE BEING PULLED THROUGH. THE BREAK OCCURRED AS TRACTION WAS APPLIED TO ADVANCE THE PEG TUBE FROM THE STOMACH THROUGH THE ABDOMINAL WALL. THE WIRE EMERGED THROUGH THE ABDOMEN BUT SNAPPED BEFORE THE PEG COULD COME THROUGH. ONLY A SHORT SEGMENT OF THE BROKEN WIRE WAS LEFT TO SECURE; HOWEVER, THE WIRE WAS FULLY RETRIEVED. THE PROCEDURE WAS BRIEFLY PAUSED, AND THE REMAINING WIRE WAS HELD WITH FORCEPS TO FACILITATE COMPLETION OF THE PULL-THROUGH. THE PEG TUBE WAS SUCCESSFULLY PLACED WITHOUT FURTHER COMPLICATION...PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23442074 ↗
• MalfunctionJul 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Remove; Difficult to Fold, Unfold or Collapse; Difficult to Remove

  IT WAS REPORTED, "PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) CANNOT BE PULLED OUT EVEN THOUGH IT SHOULD BE "TRACTION REMOVEABLE". WE HAVE STOPPED PULLING AVANO'S MIC PEG AND INSTEAD CUT ALL OF THEM."

  Patient problems: Discomfort

  MAUDE report 22563859 ↗
• MalfunctionFeb 18, 2025Difficult to Remove; Difficult to Remove

  T WAS REPORTED THE MIC-PEG TUBE HAD BEEN IN USE FOR "1-YEAR AND IT SHOULD BE REMOVED. IMPOSSIBLE TO PULL OUT THROUGH THE STOMA CHANNEL SINCE THE MATERIAL HAS BECOME TOO HARD AND STIFF. [TRIED] TO PULL IT OUT VIA THE ESOPHAGUS WITH A GASTROSCOPY IN AN ORDINARY FASHION WHEN [THE CLINICIAN WAS] UNABLE TO PULL IT OUT VIA THE STOMA CHANNEL. THE MATERIAL OF THE INTERNAL CUFF IS SO HARD THAT IT OCCLUDES THE LARYNX AND IS IMPOSSIBLE TO GET OUT THROUGH THE MOUTH. THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) IS FINALLY EXTRACTED WITH A NET USED FOR ENDOSCOPY WITHOUT HARMING THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405556 ↗
• MalfunctionDec 5, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE WAS DIFFICULT TO REMOVE. THE PATIENT HAD TO UNDERGO AN UNSCHEDULED AND NEW GASTROSCOPY PROCEDURE WITH SEDATIVES TO CUT THE PEG AND REMOVE THE PLATE WITH THE GASTROSCOPE.

  Patient problems: Insufficient Information

  MAUDE report 20856345 ↗
• MalfunctionNov 27, 2024Difficult to Remove; Difficult to Remove

  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 9611594-2024-00275 FOR THE FIRST EVENT. REFER TO 9611594-2024-00276 FOR THE SECOND EVENT. IT WAS REPORTED THE PHYSICIANS HAD DIFFICULTY REMOVING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) VIA PULL/TRACTION REMOVAL. THE PHYSICIANS PERFORMED "A GASTROSCOPY TO REMOVE THE PEG, IT WAS NOT POSSIBLE TO TAKE IT OUT WITH TRACTION." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799975 ↗
• MalfunctionNov 27, 2024Difficult to Remove; Difficult to Remove

  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 9611594-2024-00275 FOR THE FIRST EVENT. REFER TO 9611594-2024-00277 FOR THE THIRD EVENT. IT WAS REPORTED THE PHYSICIANS HAD DIFFICULTY REMOVING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) VIA PULL/TRACTION REMOVAL. THE PHYSICIANS PERFORMED "A GASTROSCOPY TO REMOVE THE PEG, IT WAS NOT POSSIBLE TO TAKE IT OUT WITH TRACTION." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799417 ↗
• MalfunctionNov 27, 2024Difficult to Remove; Difficult to Remove

  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 9611594-2024-00276 FOR THE SECOND EVENT. REFER TO 9611594-2024-00277 FOR THE THIRD EVENT. IT WAS REPORTED THE PHYSICIANS HAD DIFFICULTY REMOVING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) VIA PULL/TRACTION REMOVAL. THE PHYSICIANS PERFORMED "A GASTROSCOPY TO REMOVE THE PEG, IT WAS NOT POSSIBLE TO TAKE IT OUT WITH TRACTION." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 08-NOV-2024 STATING FOR THIS RECENT EVENT THE PHYSICIAN HAD TO PERFORM "A NEW GASTROSCOPY WHERE WE HAD TO GIVE THE PATIENT SEDATIVE MEDICATION TO CUT THE PEG AND REMOVE THE PLATE WITH THE GASTROSCOPE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799382 ↗
• MalfunctionApr 18, 2024Separation Problem; Separation Problem

  ADDITIONAL INFORMATION RECEIVED 29-APR-2024 STATING, "NO INJURIES...PATIENT COMPLAINED OF SORE THROAT FOR 2-WEEKS AFTER TUBE PULLED OUT THROUGH THE ESOPHAGUS ¿ DIFFICULT REMOVAL OF BUMPER DUE TO BUMPER NOT COLLAPSING."

  Patient problems: Foreign Body In Patient

  MAUDE report 19138805 ↗
• MalfunctionMar 25, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED THE CLINICIAN WAS THE PHYSICIAN WAS UNABLE TO TRACTION REMOVE THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACED IN (B)(6) 2022. THE PATIENT WAS SCHEDULED FOR AN ENDOSCOPY FOR PEG CHANGE. [THE] PATIENT WAS NOT ABLE TO OPEN HER MOUTH (SOME MEDICAL ISSUE) COULD NOT SCOPE. ATTEMPTED TRACTION REMOVAL AND VERY TIGHT BUT ONLY WAY TO GET IT OUT AND THE BUMPER BROKE AND HAS BEEN LEFT INTO PASS, SO THEY WILL BE ADVISED WHAT TO DO VIA [THE PHYSICIAN]." ADDITIONAL INFORMATION RECEIVED 05-MAR-2024 STATING THE "PATIENT IS HOME AND STABLE ACCORDING TO FAMILY AT THIS STAGE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18973401 ↗
• MalfunctionMar 25, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) DEVICE "COULD NOT BE TRACTION REMOVED IN ENDO SO [THE DEVICE WAS] CUT AND RETRIEVED" VIA ENDOSCOPY. THE DEVICE WAS INITIALLY PLACED (B)(6)2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 18970318 ↗
• MalfunctionMar 18, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE CLINICIAN WAS "UNABLE TO TRACTION REMOVE PEG INITIALLY PLACED IN (B)(6) 2022... THE PATIENT'S TUBE WAS SNIPPED AND DROPPED INTO STOMACH [AND] RETRIEVED." THE DEVICE REMANENT WAS REMOVED VIA ENDOSCOPY. THE DEVICE WAS REPLACED WITH A NEW 20FR DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18925458 ↗
• MalfunctionMar 12, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THERE WERE TWO EVENTS OF FOR THE FIRST EVENT IT WAS NOTED "PEG OUTREACH ATTEMPTED TO TRACTION PULL (B)(6) 2023 WOULD NOT PULL AND BUMPER DID NOT COLLAPSE. HAD ENDOSCOPY ON (B)(6) 2024 AND GASTROENTEROLOGIST TRIED TO TRACTION PULL AND NOT ABLE TO, SO RETRIEVED ENDOSCOPICALLY." THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS INITIALLY PLACED ON (B)(4) 2022. THE CURRENT STATUS OF THE PATIENT WAS REPORTED TO BE STABLE. NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889913 ↗
• MalfunctionMar 11, 2024Difficult to Remove; Difficult to Remove

  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 3006646024-2024-00007 FOR THE SECOND EVENT. IT WAS REPORTED THERE WAS EVENT IN WHICH THE "PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] COULD NOT BE REMOVED VIA TRACTION AND HAD TO BE CUT AND RETRIEVED IN ENDOSCOPY." THE DEVICE WAS INSERTED (B)(6) 2022 AND WAS IN USE FOR 15-MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874938 ↗
• MalfunctionMar 11, 2024Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED 08-APR-2024 STATED THE BROKEN DEVICE COMPONENT WAS "UNABLE TO BE RETRIEVED ENDOSCOPICALLY AND DOCTOR HAD TO LEAVE THE (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) PEG BUMPER IN SITU DUE TO RESISTANCE IN DISTAL AND PROXIMAL ESOPHAGUS WITH REMOVAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874937 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED, "DURING TRACTION REMOVAL INTERNAL BUMPER WAS SEPARATED FROM THE TUBING, CAUSING THE NEED TO GO AND RETRIEVE IT." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16961792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924065. One submission often covers many models, so check the product and lot details in each record.

• Z-2346-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
• Z-2350-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
• Z-2349-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
• Z-2348-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Z-2342-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
• Z-2343-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
• Z-2341-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
• Z-2352-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
• Z-2345-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
• Z-2347-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Comp
• Z-2351-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
• Z-2344-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL