Halyard 40979Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651409796), received between Dec 7, 2017 and Dec 23, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE PATIENT WENT TO THE HEALTHCARE FACILITY FOR REMOVAL OF A PEG TUBE THAT COULDN¿T BE REMOVED IN THE CLINICIANS OFFICE. WE WILL SAVE TUBE AND ALSO I WILL SEND INFORMATION. ADDITIONAL INFORMATION RECEIVED 03-DEC-2019 STATED THE DEVICE WAS PLACED IN THE PATIENT AT THE 2CM MARKING. THE DEVICE WAS PLACED ON (B)(6) 2019. THE PATIENT EXPERIENCED ABDOMINAL PAIN DURING THE ATTEMPTED REMOVAL BY TRACTION. SINCE THE DEVICE WAS UNABLE TO BE REMOVED BY STANDARD TRACTION PER PROTOCOL, IT HAD TO BE REMOVED BY EGD (ESOPHAGOGASTRODUODENOSCOPY) AS A FOREIGN BODY.

  Patient problems: No Code Available

  MAUDE report 9511931 ↗
• MalfunctionDec 7, 2017Material Separation; Material Separation

  IT WAS REPORTED THE ENTERAL MUSHROOM BOLSTER SEPARATED FROM THE TUBE. AS A RESULT, THE PATIENT WAS REQUIRED TO UNDERGO AN UNPLANNED ESOPHAGOGASTRODUODENOSCOPY FOR FOREIGN BODY REMOVAL. BECAUSE OF THE PATIENT'S STATUS AND PREVIOUS HEALTH HISTORY, THE PHYSICIAN DEEMED THE REMOVAL OF THE CAP NECESSARY RATHER THAN ALLOW IT TO PASS THROUGH THE DIGESTIVE TRACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7095394 ↗

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-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-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-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-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-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-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-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-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-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-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-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