Halyard 40978Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC* Safety PEG PUSH Method Kit (Over-the-Wire)-20-6.7 · Class 2 · Implant

All models of Halyard (232)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651409789), received between Mar 10, 2017 and May 22, 2018 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Break2
Device Operates Differently Than Expected1

Patient problems

No Known Impact Or Consequence To Patient2
No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 22, 2018Device Operates Differently Than Expected
UNABLE TO PASS WIRE THROUGH THE OPAQUE/WHITE PORTION OF THE EQUIPMENT.
Patient problems: No Information
MAUDE report 7533236 ↗
MalfunctionDec 12, 2017Break; Break
IT WAS REPORTED THAT THE CATHETER SEPARATED INSIDE THE PATIENT FROM THE TAPERED END OF THE PULL THROUGH. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 STATED THAT THE PATIENT DID FINE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 STATED THAT THE PORTION OF THE DEVICE THAT SEPARATED WAS RETRIEVED FROM INSIDE THE PATIENT. THE SEPARATION OCCURRED AT THE JUNCTION OF THE TAPERED HARD PLASTIC INTRODUCER AND THE SOFT SILASTIC TUBE. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7110334 ↗
MalfunctionMar 10, 2017Break; Break
IT WAS REPORTED THAT, WHEN PULLING THROUGH THE PEG TUBE, IT BROKE AND THE PART OF THE TUBE WITH THE BUMPER OBSTRUCTED THE PATIENT'S AIRWAY AND HER OXYGEN LEVEL IMMEDIATELY STARTED TO DECREASE RAPIDLY. THE DOCTOR QUICKLY WENT IN AND PUSHED IT OUT OF THE AIRWAY AND INTO THE ESOPHAGUS, THEN HAD TO GET A DEVICE TO PULL IT OUT. NO ADDITIONAL INFORMATION AVAILABLE FOR THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6394584 ↗

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-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-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-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-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-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-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-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-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	`10680651409789`
Brand	Halyard
Model	40978
Catalog no.	7170-20
Company	Avanos Medical, Inc.
Product code	KNT · TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Class	Class 2
FDA submission	K924065
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 20, 2020

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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