MIC PEG TUBE 8160-24Recalls & reported problems

Avanos Medical, Inc. · MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit® Connectors - 24 Fr - PULL · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770006468), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Too Rigid or Stiff1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 15, 2026Material Too Rigid or Stiff
IT WAS REPORTED THE SURGEONS NOTED "WHEN IT COMES TO REMOVING THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE, THAT PLASTIC DONUT AT THE TIP IS SO STIFF AND HARD, THEY ARE UNABLE TO PULL IT OUT AT BEDSIDE OR IN THEIR CLINICS. INSTEAD, THEY HAVE TO TAKE THE PATIENT BACK TO SURGERY FOR REMOVAL' VIA ENDOSCOPIC SURGICAL REMOVAL. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194682 ↗

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

Device details

UDI-DI	`00350770006468`
Brand	MIC PEG TUBE
Model	8160-24
Company	Avanos Medical, Inc.
Product code	KNT · Tubes, gastrointestinal (and accessories)
Class	Class 2
FDA submission	K924065
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 4, 2025

Device type (GMDN): Gastrostomy tube

A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.

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All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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