AVANOS 40979Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00350770409795), received between May 3, 2019 and Jun 16, 2025 — classified as 1 death, 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA FDA MAUDE ADVERSE EVENT REPORT NUMBER MW5164184, ¿PATIENT UNDERWENT EGD FOR PEG PLACEMENT. AN AVANOS 20FR MICKEY PEG PLACEMENT WAS PLACED USING STANDARD PULL TECHNIQUE WITHOUT ISSUE. AFTER PLACEMENT, REPEAT INSPECTION OF THE ESOPHAGUS NOTED BLOOD WITH A SMALL, ~10MM MUCOSAL LEVEL TEAR OF THE DISTAL ESOPHAGUS. THIS WAS EXAMINED CAREFULLY AND NO DEEPER INJURY WAS FOUND. IT STOPPED BLEEDING ON ITS OWN, AND THE PROCEDURE WAS COMPLETED. THE PATIENT AWOKE APPROPRIATELY AFTER THE PROCEDURE WITH NO ACUTE ISSUES.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s) of Esophagus

  MAUDE report 22213361 ↗
• InjuryJan 3, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED GE [GASTRO-ESOPHAGEAL] JUNCTION WAS BLEEDING DURING POST PEG [[GASTRO-ESOPHAGEAL] PLACEMENT PROCEDURE AND THE PROVIDER HAD TO CLIP THE TEAR. THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21068595 ↗
• MalfunctionApr 18, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH / FDA USER FACILITY REPORT 2300530000-2023-8040 THE FOLLOWING INFORMATION: DOCTOR WAS PERFORMING A BEDSIDE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE. WHILE REMOVING THE RETRIEVAL SNARE, THE SNARE BROKE OFF AND DOCTOR HAD TO MANUALLY RETRIEVE THE ITEM. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BEDSIDE PEG PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19138822 ↗
• MalfunctionMar 28, 2024

  DOCTOR WAS PERFORMING A BEDSIDE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE. WHILE REMOVING THE RETRIEVAL SNARE, THE SNARE BROKE OFF AND DOCTOR HAD TO MANUALLY RETRIEVE THE ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989990 ↗
• MalfunctionDec 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS UNABLE TO BE REMOVED BY TRACTION REMOVAL DESPITE USING PROPER TECHNIQUE. THE PEG HAD TO BE REMOVED VIA ENDOSCOPY THROUGH THE PATIENT MOUTH. THERE WAS NO INJURY REPORTED. ENDOSCOPY REPORT NOTED: ¿STOMACH: THE TRACTION-REMOVABLE PEG WAS IDENTIFIED IN THE STOMACH BODY. THE BUMPER WAS FREELY MOBILE AND NOT [BURIED]. WE INITIALLY ATTEMPTED TRACTION REMOVAL UNDER ENDOSCOPIC VISUALIZATION. THE BUMPER IS SOMEWHAT BROADER THAN OTHER TRACTION REMOVABLE BUMPERS AND MORE ELASTIC. AS SUCH, ONCE THE BUMPER COLLAPSED AS IT WAS PASSING INTO THE PEG TRACT, IT WOULD SPRING BACK INTO THE GASTRIC BODY, PREVENTING REMOVAL. WE THEN DECIDED TO REMOVE THE BUMPER THROUGH THE MOUTH. WE SECURED THE BUMPER WITH A ROTH NET, THEN CUT THE PEG TUBING ABOUT 5 CM FROM THE SKIN. WE WERE THEN ABLE TO REMOVE THE PEG THROUGH THE MOUTH. DUODENUM: THE DUODENAL MUCOSA SHOWED NO ABNORMALITIES IN THE ENTIRE DUODENUM. THE GASTROSCOPE WAS THE SLOWLY WITHDRAWN AND REMOVED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369765 ↗
• MalfunctionAug 21, 2023Malposition of Device; Malposition of Device

  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 3006646024-2023-00033 FOR THE SECOND EVENT. IT WAS REPORTED, THE HOSPITAL EXPERIENCED AN INSTANCE WHERE THE PATIENT'S ESOPHAGUS WAS PERFORATED WHILE USING THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY). NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 15-AUG-2023 STATES THERE WAS A 2CM DISTAL MUCOSAL TEARS IN ESOPHAGUS WITH CONTINUOUS BLEEDING REQUIRING ENDOSCOPIC CLIPS TO CONTROL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17585312 ↗
• InjuryAug 21, 2023Malposition of Device; Malposition of Device

  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 3006646024-2023-00032 FOR THE FIRST EVENT. IT WAS REPORTED, THE HOSPITAL EXPERIENCED AN INSTANCE WHERE THE PATIENT'S ESOPHAGUS WAS PERFORATED WHILE USING THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY). NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 15-AUG-2023 STATING THE PATIENT HAD AN UNSPECIFIED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE THAT HAD BEEN DISLODGE AND REQUIRED NEW PLACEMENT. THERE WERE THREE ESOPHAGUS DEEP MUCOSAL TEARS, ONE BELIEVED TO BE PERFORATION THROUGH THE MUCOSA. THE PATIENT WAS TREATED ENDOSCOPICALLY AND CLIPPED AT ALL THREE TEAR SITES. A COMPUTED TOMOGRAPHY (CT) OF THE CHEST, ABDOMEN AND PELVIS WAS PERFORMED AND DID NOT SHOW PNEUMOMEDIASTINUM OR EXTRAESOPHAGEAL AIR.

  Patient problems: Perforation

  MAUDE report 17583939 ↗
• MalfunctionJun 30, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 17-JUL-2023 STATING "IT WAS REPORTED THIS OCCURRED DURING REMOVAL."

  Patient problems: Foreign Body In Patient

  MAUDE report 17240452 ↗
• MalfunctionJun 30, 2023Break; 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 3006646024-2023-00027 FOR THE SECOND EVENT. IT WAS REPORTED THERE WERE TWO PROCEDURES IN WHICH THE BUMPER PART OF THE PEG BROKE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 15-JUN-2023 STATED THE PATIENT IS BEING MONITOR FOR ANY SYMPTOMS, NO INTERVENTION IS PLANNED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 17240197 ↗
• InjuryFeb 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A PIECE OF THE CATHETER CAME OFF INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11JAN2023 REPORTED, THE HYPODERMIC NEEDLE WAS STUCK IN THE PATIENT¿S STOMACH; THEY BELIEVED THE PIECE WAS RETRIEVED. THE PATIENT RECEIVED A FEEDING TUBE AND WAS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Foreign Body In Patient

  MAUDE report 16277230 ↗
• MalfunctionFeb 1, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A PIECE OF THE CATHETER CAME OFF INSIDE THE PATIENT. THERE WAS NO MEDICAL INTERVENTION OR INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 30JAN2023 REPORTED, IT WAS THE CATHETER THAT COVERS THE NEEDLE. THERE WAS NO MEDICAL INTERVENTION OR INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16277226 ↗
• InjuryFeb 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE PEG TUBE BUMPER, THE DOCTOR NOTED ESOPHAGEAL TRAUMA; THE PROCEDURE WAS COMPLETED AND NO MEDICAL INTERVENTION WAS PERFORMED OF THE NOTED ESOPHAGEAL TRAUMA. ADDITIONAL INFORMATION RECEIVED ON 26JAN2022 STATED THAT THE PATIENT WAS DOING WELL AND TOLERATING TUBE FEEDINGS WITHOUT DIFFICULTY.

  Patient problems: Insufficient Information

  MAUDE report 13457019 ↗
• InjuryDec 13, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THE DIGESTIVE HEALTH FEEDING TUBE (PULL PEG) WAS PLACED BY THE PHYSICIAN. WHEN THE PEG WAS BEING PULLED DOWN THE ESOPHAGUS THE PHYSICIAN NOTICED SMALL TEARING AND DILATION OF THE ESOPHAGUS BY THE INTERNAL BUMPER OF THE PEG TUBE. THE PHYSICIAN INDICATED THAT IT SEEMED LIKE THE BUMPER WAS TOO STIFF. THE PEG TUBE WAS PLACED IN THE PATIENT WITH NO OTHER ISSUES. THE USER NOTED THAT ¿FOR AN INITIAL PEG TUBE INSERTION ANTIBIOTICS ARE GIVEN PROPHYLACTICALLY." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12991735 ↗
• MalfunctionJun 24, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING TRACTION REMOVAL OF A PEG TUBE, THE BUMPER DETACHED FROM THE TUBE. THE TUBE HAD BEEN IN PLACE SINCE (B)(6) 2019. THE BUMPER PASSED THROUGH THE PATIENT WITHOUT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10191539 ↗
• MalfunctionApr 5, 2020Break; Break

  AVANOS MEDICAL, INC. 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 3006646024-2020-00007 FOR THE FIRST EVENT. REFER TO 3006646024-2020-00008 FOR THE SECOND EVENT. ADDITIONAL INFORMATION RECEIVED 12-MAR-2020 STATED: THERE WERE AT LEAST 2 INSTANCES WHERE A BUMPER SEPARATED FROM THE TUBE. NEITHER PATIENT HAD AN UNUSUAL BODY HABITS IN THE SENSE THAT I DID NOT EXPECT THE ISSUE WAS RELATED TO ABDOMINAL OBESITY. THE INITIAL COMPLAINT WAS REFERENCED AS IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5093201 RECEIVED ON (B)(6) 2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: HALYARD G TUBE WHICH WAS ALMOST 2 YRS OLD AND WAS SUPPOSED TO BE REMOVABLE BY EXTERNAL TRACTION, BROKE UPON REMOVAL ATTEMPT, LEAVING THE INTERNAL BUMPER INSIDE THE STOMACH. URGENT EGO WAS REQUIRED TO REMOVE THE INTERNAL BUMPER FROM THE STOMACH. BUMPER WAS FELT TO TOO LARGE TO BE ALLOWED TO PASS SPONTANEOUSLY SIGNIFICANT CONCERN FOR SMALL BOWEL OBSTRUCTION REQUIRING LAPAROTOMY. IF BUMPER PASSED BEYOND STOMACH DUE TO PERISTALSIS THEREFORE WAS SIGNIFICANT URGENCY

  Patient problems: Foreign Body In Patient

  MAUDE report 9927135 ↗
• MalfunctionApr 5, 2020Break; Break

  AVANOS MEDICAL, INC. 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 3006646024-2020-00008 FOR THE SECOND EVENT. REFER TO 3006646024-2020-00009 FOR THE THIRD EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5093201 RECEIVED ON (B)(6)2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: HALYARD G TUBE WHICH WAS ALMOST 2 YRS OLD AND WAS SUPPOSED TO BE REMOVABLE BY EXTERNAL TRACTION, BROKE UPON REMOVAL ATTEMPT, LEAVING THE INTERNAL BUMPER INSIDE THE STOMACH. URGENT EGO WAS REQUIRED TO REMOVE THE INTERNAL BUMPER FROM THE STOMACH. BUMPER WAS FELT TO TOO LARGE TO BE ALLOWED TO PASS SPONTANEOUSLY SIGNIFICANT CONCERN FOR SMALL BOWEL OBSTRUCTION REQUIRING LAPAROTOMY. IF BUMPER PASSED BEYOND STOMACH DUE TO PERISTALSIS THEREFORE WAS SIGNIFICANT URGENCY FOR ENDOSCOPY. EGD REVEALED SEPARATED INTERNAL BUMPER IN STOMACH SEE ABOVE. UNFORTUNATELY, THIS IS THE MOST DRAMATIC INCIDENT RELATED TOG TUBE AT MY FACILITY. BUT I HAVE SEEN SEVERAL G TUBES OF THIS BRAND RECENTLY THAT WERE DEGRADED WAY BEYOND WHAT THEIR CALENDAR AGE WOULD INDICATE. I

  Patient problems: Foreign Body In Patient

  MAUDE report 9927118 ↗
• MalfunctionApr 5, 2020Break; Break

  AVANOS MEDICAL, INC. 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 3006646024-2020-00007 FOR THE FIRST EVENT. REFER TO 3006646024-2020-00009 FOR THE THIRD EVENT. ADDITIONAL INFORMATION RECEIVED 12-MAR-2020 STATED: THERE WERE AT LEAST 2 INSTANCES WHERE A BUMPER SEPARATED FROM THE TUBE. NEITHER PATIENT HAD AN UNUSUAL BODY HABITS IN THE SENSE THAT I DID NOT EXPECT THE ISSUE WAS RELATED TO ABDOMINAL OBESITY. THE INITIAL COMPLAINT WAS REFERENCED AS IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5093201 RECEIVED ON (B)(6) 2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: HALYARD G TUBE WHICH WAS ALMOST 2 YRS OLD AND WAS SUPPOSED TO BE REMOVABLE BY EXTERNAL TRACTION, BROKE UPON REMOVAL ATTEMPT, LEAVING THE INTERNAL BUMPER INSIDE THE STOMACH. URGENT EGO WAS REQUIRED TO REMOVE THE INTERNAL BUMPER FROM THE STOMACH. BUMPER WAS FELT TO TOO LARGE TO BE ALLOWED TO PASS SPONTANEOUSLY SIGNIFICANT CONCERN FOR SMALL BOWEL OBSTRUCTION REQUIRING LAPAROTOMY. IF BUMPER PASSED BEYOND STOMACH DUE TO PERISTALSIS THEREFORE WAS SIGNIFICANT URGENCY

  Patient problems: Foreign Body In Patient

  MAUDE report 9927115 ↗
• MalfunctionJan 9, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WAS "UNABLE TO REMOVE THE PEG IN CLINIC PERCUTANEOUSLY WITH 2 ATTEMPTS." THE PATIENT WAS REQUIRED TO HAVE AN EGD [ESOPHAGOGASTRODUODENOSCOPY]. ADDITIONAL INFORMATION RECEIVED ON 30-DEC-2019 INDICATED THE PEG TUBE WAS IN PLACE FOR 5 MONTHS (B)(6) 2019 TO (B)(6) 2019). THE PERSON REMOVING THE PEG TUBE HAD 25 YEARS EXPERIENCE WORKING IN GASTROENTEROLOGY. THE PATIENT HAD THE PEG ENDOSCOPICALLY REMOVED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9568499 ↗
• DeathMay 3, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE SURGEON "HAD DIFFICULTY REMOVING A 7180-20 PEG. THE PATIENT REFUSED AN ENDOSCOPY AT THAT TIME. [THE SURGEON] CUT THE TUBE AT SKIN LEVEL LEAVING THE BUMPER IN THE PATIENT¿S STOMACH. THE INTENTION WAS THAT HOPEFULLY THE BUMPER WOULD PASS. THE BUMPER CREATED AN OBSTRUCTION AND THE PATIENT DIED."

  Patient problems: Death; Obstruction/Occlusion

  MAUDE report 8579426 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL