AVANOS 44616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770446165), received between Jul 14, 2022 and Sep 7, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2022Difficult to Remove; Difficult to Remove

  THE REPORT WAS INITIALLY RECEIVED ON 23JUN2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372662 ↗
• MalfunctionAug 30, 2022Difficult to Remove; Difficult to Remove

  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 THIRD OF THREE REPORTS. REFER TO 3006646024-2022-00067 FOR THE FIRST REPORT. REFER TO 2026095-2022-00068 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE GASTROINTESTINAL (GI) PHYSICIAN WAS UNABLE TO REMOVE THE TUBE FROM THE PATIENT AS PER NORMAL PROCEDURE AND HAD TO CUT THE TUBE; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30JUN2022 REPORTED THAT THE TUBE WAS PLACED ON (B)(6) 2022; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 01JUL2022 REPORTED THE TUBE WAS IN PLACE FOR 6 WEEKS AND CONFIRMED THERE WAS NO PATIENT INJURY. SHOW LESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324775 ↗
• MalfunctionJul 14, 2022Difficult to Remove; Difficult to Remove

  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 2026095-2022-00068 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE GASTROINTESTINAL (GI) PHYSICIAN WAS UNABLE TO REMOVE THE TUBE FROM THE PATIENT AS PER NORMAL PROCEDURE AND HAD TO CUT THE TUBE; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30JUN2022 REPORTED THAT THE TUBE WAS PLACED ON (B)(6) 2022; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 01JUL2022 REPORTED THE TUBE WAS IN PLACE FOR 6 WEEKS AND CONFIRMED THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023377 ↗
• MalfunctionJul 14, 2022Difficult to Remove; Difficult to Remove

  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 2026095-2022-00067 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE GASTROINTESTINAL (GI) PHYSICIAN WAS UNABLE TO REMOVE THE TUBE FROM THE PATIENT AS PER NORMAL PROCEDURE AND HAD TO CUT THE TUBE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023177 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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