AVANOS 44626Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770446264), received between Oct 24, 2019 and Oct 2, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2025Migration; Migration

  IT WAS REPORTED THAT SEVEN DAYS AFTER INSERTION, THE PATIENT RETURNED TO THE HOSPITAL WITH ABDOMINAL PAIN AND FEVER. THE COLLAR HAD MIGRATED INTO THE WALL. THE ENDOSCOPIC PROCEDURE DID NOT ALLOW THE CATHETER TO BE REMOVED IN ITS ENTIRETY; THE PATIENT WAS TRANSFERRED TO SURGERY TO HAVE IT REMOVED AND A JEJUNOSTOMY PERFORMED. (B)(4). COMPLAINT RCVD 5 SEPTEMBER 2025. STATING: "SEVEN DAYS AFTER INSERTION, THE PATIENT RETURNED TO THE CLINIC COMPLAINING OF ABDOMINAL PAIN AND FEVER. SHE WAS TAKEN BACK TO THE OPERATING ROOM FOR A FIBROSCOPY. THE DOCTOR FOUND THAT THE COLLAR HAD MIGRATED INTO THE WALL. THE ENDOSCOPIC PROCEDURE DID NOT ALLOW THE CATHETER TO BE REMOVED IN ITS ENTIRETY; THE PATIENT WAS TRANSFERRED TO SURGERY TO HAVE IT REMOVED AND A JEJUNOSTOMY PERFORMED." NO INJURY. NO SAMPLE AVAILABLE. -MDOIG. 8 SEPTEMBER 2025: INCIDENT CHANGED FROM 'CAUSES ESOPHAGEAL TRAUMA' TO 'REACTION'. WAITING FOR ADDITIONAL INFO. -MDOIG. 8 SEPTEMBER 2025: ANSM DOCUMENTS RCVD, REF: (B)(4). SATAING IN FRENCH: "DATE DE SURVENUE: ON (B)(6) 2025. DESCRIPTION DE L¿INCIDENT: POSE D'UNE SONDE DE GASTROSTOMIE POUR ALIMENTATION (CARCINOME DU 1/3 MOYEN DE L'¿SOPHAGE) LE ON (B)(6) 2025. PAS DE COMPLICATION. PATIEN

  Patient problems: Fever; Pain

  MAUDE report 23206659 ↗
• InjuryJun 10, 2021Migration; Migration

  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 3006646024-2021-00009 FOR THE FIRST REPORT. IT WAS REPORTED THAT A FEW DAYS AFTER INSERTION, THE GASTROSTOMY WAS NO LONGER IN THE PATIENT'S STOMACH. THE INTERNAL FLANGE HAD MIGRATED INTO THE SUBCUTANEOUS TISSUE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A LAPAROTOMY TO REMOVE THE KIT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11979008 ↗
• InjuryJun 10, 2021Migration; Migration

  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 3006646024-2021-00010 FOR THE SECOND REPORT. IT WAS REPORTED THAT A FEW DAYS AFTER INSERTION, THE GASTROSTOMY WAS NO LONGER IN THE PATIENT'S STOMACH. THE INTERNAL FLANGE HAD MIGRATED INTO THE SUBCUTANEOUS TISSUE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A LAPAROTOMY TO REMOVE THE KIT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11978932 ↗
• InjuryJul 16, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT THE PATIENT FELT PAIN WHEN HANDLING THE GASTROSTOMY TUBE 6 MONTHS AFTER PLACEMENT. FIBROSCOPY WAS PERFORMED ON (B)(6) 2020 AND IT WAS FOUND THAT THE "PROBE RETENTION SYSTEM WAS NO LONGER VISIBLE IN THE WALL." SURGICAL REMOVAL OF THE RETENTION SYSTEM [BUMPER] WAS REQUIRED. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT FOR A "CLINICAL AND BIOLOGICAL INFLAMMATORY SYNDROME." ADDITIONAL INFORMATION RECEIVED 30-JUN-2020 INDICATED "THE FACTORS FAVORING THE INCLUSION OF THE DEVICE IN THE GASTRIC WALL IN THIS CASE ARE PROBABLY A RAPID AND SIGNIFICANT WEIGHT GAIN, AND A HEAVY IMMUNOSUPPRESSIVE TREATMENT, THEREFORE WEAKENED GROUND AND THE APPEARANCE TO THE BLOCK SHOWS A GRADUAL MIGRATION OF THE DEVICE. PATIENT'S CONDITION IS FINE."

  Patient problems: Inflammation; Pain

  MAUDE report 10285690 ↗
• InjuryJul 16, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT THE PATIENT FELT PAIN WHEN HANDLING THE GASTROSTOMY TUBE 6 MONTHS AFTER PLACEMENT, WHICH LED TO STOP THE ENTERAL FEEDING. FIBROSCOPY WAS PERFORMED ON (B)(6) 2020 AND IT WAS FOUND THAT THE "DOME OF THE GASTROSTOMY TUBE WAS NO LONGER VISIBLE IN THE WALL." THE PROBE WAS REMOVED BY EXTERNAL TRACTION. ADDITIONAL INFORMATION RECEIVED 30-JUN-2020 INDICATED "THE FACTORS FAVORING THE INCLUSION OF THE DEVICE IN THE GASTRIC WALL IN THIS PARTICULAR CASE ARE MOST CERTAINLY A RELUCTANCE TO GASTROSTOMY CARE AND MOBILIZATION FOLLOWING A WALL INFECTION, AND A HEAVY IMMUNOSUPPRESSIVE TREATMENT, THEREFORE A FAIRLY FRAGILE AREA AND A GRADUAL MIGRATION OF THE DEVICE HAS BEEN OBSERVED. PATIENT'S CONDITION IS FINE."

  Patient problems: Pain

  MAUDE report 10285656 ↗
• MalfunctionOct 24, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT WHEN THE PATIENT CAME TO THE CLINIC TO GET THE FEEDING TUBE REMOVED, IT WAS FOUND THAT THE RETENTION BUTTON OF THE FEEDING TUBE HAD MIGRATED UNDER THE SKIN OF THE PATIENT. THE PATIENT WILL REQUIRED SURGICAL EXTRACTION OF THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED 11 OCT 2019. THE PATIENT IS IN GOOD CONDITION. THE PATIENT HAD GONE TO GET THEIR FEEDING TUBE REMOVED DUE TO THE STOPPING OF NUTRITION. PER ADDITIONAL INFORMATION RECEIVED 22 OCT 2019, THE TUBE HAD BEEN IN PLACE FROM (B)(6) 2019 TO (B)(6) 2019.

  Patient problems: Foreign Body In Patient

  MAUDE report 9235434 ↗

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-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-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-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-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-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-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-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-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-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-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-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