Halyard 40982Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651409826), received between Feb 14, 2017 and Feb 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 14, 2017Break; Break

  IT WAS REPORTED BY A NURSE THAT, "DURING PLACEMENT OF THE PEG TUBE, WHILE PULLING THE TAPERED TIP OF THE TUBE THROUGH THE ABDOMINAL WALL, THE WHITE STRAIN RELIEF CONNECTION PORTION OF THE TUBE LODGED IN THE WALL OF THE ABDOMEN, SNAPPING APART FROM THE BUMPER PORTION OF THE TUBE. ATTEMPTS TO RETRIEVE THE SEPARATED PIECE WITH A SNARE VIA ENDOSCOPY WERE UNSUCCESSFUL, THEREFORE AN INCISION WAS MADE IN THE ABDOMEN TO EXPOSE AND RETRIEVE THE SEPARATED PIECE. THE PLACEMENT OF THE TUBE WAS THEN COMPLETED WITH THE INTERNAL BUMPER PLACED AGAINST THE STOMACH WALL." THERE WAS NO REPORTED INJURY AND THERE WAS NO FURTHER INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED ON 02-FEB-2017 THAT STATES, "WHILE ATTEMPTING TO PULL THE PEG TUBE UP FROM THE STOMACH THROUGH THE ABDOMINAL WITH THE PHYSICIAN HOLDING TENSION, THE PEG TUBE SEPARATED AT THE WHITE HEAT SEAL WITH THE IMPLANT PORTION OF THE PEG RETAINED IN THE PATIENT¿S TISSUE. THE BUMPER WAS VISUALIZED IN THE STOMACH WITH THE EGD SCOPE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE WHITE BUMPER OF THE PEG KIT USING MULTIPLE DEVICES AND WAS UNSUCCESSFUL IN RETRIEVING THE PEG TUBE. THE PHYSICIAN THEN DECIDED TO USE A FORCEP AT THE INCISION SITE AND WAS ABLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6330503 ↗

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-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-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-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-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-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-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-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-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