AVANOS 40983Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770409832), received between Mar 9, 2022 and Apr 3, 2025 — classified as 4 injuries, 2 malfunctions.

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

• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THERE WAS AN INCIDENT WITH ONE OF THE AVANOS PEG KITS, IN WHICH THE STYLET WAS ¿SUCKED¿ INTO A PATIENT¿S SUBCUTANEOUS TISSUE." THE PATIENT REQUIRED ADDITIONAL BEDSIDE PROCEDURE TO REMOVE RETAINED STYLET. THE PATIENT WAS STABLE AFTER REMOVAL OF THE RETAINED STYLET.

  Patient problems: Foreign Body In Patient

  MAUDE report 21763042 ↗
• MalfunctionMar 13, 2025

  THE 17-GAUGE INTRODUCER SAFETY NEEDLE IN THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) KIT THAT WAS OPENED CAUSED THE CATHETER TO BE SHREDDED AND WAS NOT ABLE TO BE USED. ANOTHER KIT WAS OPENED, THERE WAS DAMAGE, BUT THE WIRE WAS ABLE TO BE PASSED THROUGH. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592716 ↗
• InjuryNov 4, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED DURING MIC PEG PLACEMENT AN ESOPHAGEAL TEAR OCCURRED. ADDITIONAL INFORMATION RECEIVED 15-OCT-2024 RECEIVED STATING, "HEMOCLIPS PLACED FOR HEMOSTASIS." THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20599793 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 20MAY2025 VIA FDA MAUDE ADVERSE EVENT REPORT MW5161232, "ESOPHAGEAL TEAR NOTED AFTER PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE REPLACED, USING MIC SAFETY PEG KIT 24FR PULL. AFTER DEVICE WAS PULLED THROUGH THE ESOPHAGUS DURING PLACEMENT, THE PROVIDER NOTICED 1 SUPERFICIAL, DISTAL ESOPHAGEAL TEAR. THE INJURY WAS NOT ACTIVELY BLEEDING AND THERE WERE NO SIGNS OF PERFORATION. MANUFACTURER NOTIFIED¿.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 20559403 ↗
• InjuryMar 9, 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 3006646024-2022-00009 FOR THE FIRST REPORT. IT WAS REPORTED THAT THERE WAS AN INCIDENT INVOLVING THE SAFETY SCALPEL IN THE PEG KIT; A USER CUT THEMSELVES WHEN OPENING THE SCALPEL. ADDITIONAL INFORMATION RECEIVED 15FEB2022 REPORTED THAT A MEMBER OF PERSONNEL WAS INJURED WHEN ATTEMPTING TO REMOVE THE PLASTIC SHEATH ON THE BLADE THAT COMES WITH THE PEG SCALPEL KIT. THE EMPLOYEE WAS EVALUATED BY THE OCCUPATIONAL HEALTH DEPARTMENT AND THE WOUND WAS DRESSED WITH AN ANTIBIOTIC APPLICATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13712832 ↗
• InjuryMar 9, 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 3006646024-2022-00010 FOR THE SECOND REPORT . IT WAS REPORTED THAT THERE WAS AN INCIDENT INVOLVING THE SAFETY SCALPEL IN THE PEG KIT; A USER CUT THEMSELVES WHEN OPENING THE SCALPEL. ADDITIONAL INFORMATION RECEIVED 15FEB2022 REPORTED THAT AN EXPERIENCED SENIOR SURGEON SLASHED HER FINGER (1 CM LONG), WHEN TRYING TO REMOVE THE PLASTIC PROTECTIVE SHEATH ON THE 11-BLADE THAT COMES WITH THE PEG KIT 24F; REPORTEDLY, IT WAS ON TOO TIGHTLY AND WAS VERY HARD TO TAKE OFF. THE SURGEON WAS EVALUATED BY THE OCCUPATIONAL HEALTH DEPARTMENT AND SUTURES WERE RECOMMENDED; THE SURGEON DECIDED TO MANAGE THE CUT WITH DERMABOND/STERI-STRIPS AFTER THE BLEEDING WAS CONTROLLED WITH PROLONGED PRESSURE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13711887 ↗

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-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-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-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-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-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-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-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-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-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-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