Halyard 40977Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10680651409772), received between Apr 3, 2017 and Feb 20, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED AN ESOPHAGEAL TEAR FROM THE DEVICE BUMPER DURING PEG TUBE PLACEMENT. TWO CLIPS WERE PLACED TO STOP THE BLEEDING. NO FURTHER MEDICAL INTERVENTION WAS PERFORMED. THE TUBE HAD BEEN LUBRICATED PRIOR TO PLACEMENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS STABLE AND THE PEG TUBE IS WORKING WITHOUT ISSUE. THE PATIENT HAD NO HISTORY OF ESOPHAGEAL STRICTURE, NARROWING, OR VARICES. THE PHYSICIAN DID NOT REPORT SEEING ANYTHING ABNORMAL DURING TUBE PLACEMENT. THE CUSTOMER REPORTED THAT "THE PATIENT WAS OLDER, SO TISSUE IS NOT AS VIABLE." THE PEG TUBE WAS PLACED DUE TO THE PATIENT BEING UNABLE TO TAKE ANYTHING BY MOUTH. THE PATIENT WAS A FEMALE IN HER 80S, WEIGHT UNKNOWN. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 7284003 ↗
• MalfunctionNov 3, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE ON 30-NOV-2017. "THE CUSTOMER STATES, SHE WAS TOLD THE BUMPER DID NOT COME OFF DURING THE ATTEMPTS TO REMOVE THE TUBE. THEY WERE CONCERNED IT WOULD COME OFF, AND DECIDED TO TAKE THE PATIENTS TO THE ENDOSCOPY SUITE TO REMOVE THEM. THERE WERE THREE PATIENTS AFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000328 ↗
• MalfunctionNov 3, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE ON 30-NOV-2017. "THE CUSTOMER STATES, SHE WAS TOLD THE BUMPER DID NOT COME OFF DURING THE ATTEMPTS TO REMOVE THE TUBE. THEY WERE CONCERNED IT WOULD COME OFF, AND DECIDED TO TAKE THE PATIENTS TO THE ENDOSCOPY SUITE TO REMOVE THEM. THERE WERE THREE PATIENTS AFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000318 ↗
• MalfunctionNov 3, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPRESENTATIVE ON 30-NOV-2017. "THE CUSTOMER STATES, SHE WAS TOLD THE BUMPER DID NOT COME OFF DURING THE ATTEMPTS TO REMOVE THE TUBE. THEY WERE CONCERNED IT WOULD COME OFF, AND DECIDED TO TAKE THE PATIENTS TO THE ENDOSCOPY SUITE TO REMOVE THEM. THERE WERE THREE PATIENTS AFFECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7000313 ↗
• MalfunctionApr 3, 2017Break; Break

  IT WAS REPORTED THAT, A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WAS PLACED ON (B)(6) 2017, THE HEALTH CARE WORKER WAS TRYING TO REPLACE THE (PEG) TUBE WITH A BALLOON RETAINED TUBE. WHEN ATTEMPTING TO REMOVE THE PEG VIA TRACTION, THE BUMPER DETACHED AND REMAINED INSIDE THE PATIENT. THE PATIENT WAS TAKEN TO ENDOSCOPY TO RETRIEVE THE BUMPER. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6455231 ↗

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-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-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-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-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-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-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-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-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-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-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-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