AVANOS 40977Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770409771), received between Aug 14, 2020 and Dec 20, 2023 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PER ADDITIONAL INFORMATION RECEIVED ON 29DEC2023, "THE PEG TUBE WAS PLACED IN THE PATIENT WITHOUT FURTHER INCIDENT.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 18369758 ↗
• DeathMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00046 FOR THE SECOND REPORT. THE PHYSICIAN REPORTED, THE EXTERNAL BOLSTER ON THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WAS LOOSE RESULTING IN TUBE DISPLACEMENT. THE ELDERLY PATIENT WAS TRANSFERRED TO LONG TERM CARE (LTC) FOLLOWING THE PROCEDURE, THE NURSING STAFF REPORTED LEAKING AT THE SITE. THE PATIENT RETURNED TO ENDOSCOPY (ED) AND TUBE MISPLACEMENT WAS NOTED; THE PATIENT PASSED A FEW DAYS LATER OF SEPSIS RELATED COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 08APR2022 REPORTED, AFTER THE TUBE PLACEMENT, THE BOLSTER WAS NOTED TO BE LOOSER THAN NORMAL AND THE BOLSTER WAS STRENGTHENED WITH A SILK SUTURE, THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT WAS READMITTED, THROUGH THE EMERGENCY ROOM (ER), WITH A DIAGNOSIS OF PERITONITIS. UPON EXAMINATION IN THE ER THE BOLSTER WAS NOTED TO BE FAR FROM THE ABDOMINAL WALL AND THERE WAS LEAKAGE AROUND THE TUBE; IT WAS ADDITIONALLY NOTED THAT THE PATIENT HAD A FIRM AND TENDER ABDOMEN. THE NURSING HOME STAFF REPO

  Patient problems: Sepsis

  MAUDE report 14304223 ↗
• MalfunctionMay 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00045 FOR THE FIRST REPORT. THE PHYSICIAN REPORTED, THE EXTERNAL BOLSTER ON THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WAS LOOSE RESULTING IN TUBE DISPLACEMENT. THE PEG WAS PLACED AND A LOOSE EXTERNAL BOLSTER WAS NOTED, IT WAS REINFORCED/SECURED WITH SUTURES TO PREVENT MISPLACEMENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 REPORTED THAT THE BOLSTER FELT VERY LOOSE AND WAS REINFORCED WITH A SILK SUTURE AND WAS ALSO BEING HELD IN PLACE WITH THE TUBE CLAMPING DEVICE. IT WAS NOTED THAT LEAKAGE WAS A PROBLEM AND AFTER SOME INVESTIGATION IT WAS DETERMINED THAT THE BOLSTER WAS FOR A 24 FRENCH (FR) TUBE AND THE TUBE IN THE KIT WAS A 20FR TUBE. A NEW KIT WAS OPENED, AND IT WAS VERIFIED TO BE A 20 FR, WHICH FIXED THE PROBLEM AND THE PATIENT WAS DISCHARGED AND WAS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281978 ↗
• MalfunctionOct 27, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED: DOCTOR WAS EXCHANGING THE G-TUBE AT THE BEDSIDE AND THE BUMPER DID NOT COME OUT WHEN THE G-TUBE WAS REMOVED. PATIENT NEEDED TO GO TO THE OR TO HAVE THE FOREIGN BODY REMOVED IN THE PATIENT'S STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 12708469 ↗
• MalfunctionAug 14, 2020Break; Break

  IT WAS REPORTED FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) THE FOLLOWING INFORMATION: THE CONNECTOR THAT TIGHTENS AND LOOSENS SNARE BECAME DISCONNECTED FROM THE HANDPIECE. CONNECTOR WAS RETRIEVED FROM PATIENT CAVITY. DATE OF EVENT: (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED 03-AUG-2020 STATED THERE WAS NO REPORTED PATIENT INJURY RELATED TO THE INCIDENT. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE VIA SNARE ASSIST.

  Patient problems: Foreign Body In Patient

  MAUDE report 10410661 ↗

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-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-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-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-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-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-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-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-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-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-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-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