Halyard 94829Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651948295), received between Jun 19, 2018 and Jul 18, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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

• MalfunctionJul 18, 2018Material Rupture

  MIC-KEY WAS PLACED INTO THE STOMACH. SEVEN (7) DAYS LATER, THE NURSING STAFF HEARD AN AIR ESCAPING SOUND AND NOTED THAT THE PATIENT'S G-TUBE WAS FALLING OUT. IT WAS NOTED THAT THERE WAS NO TENSION ON THE TUBING. ONCE THE TUBE WAS REMOVED IT WAS DISCOVERED THAT THE BALLOON ON THE MIC-KEY HAS RUPTURED. THE MIC-KEY WAS REPLACED WITH A NEW DEVICE WITHOUT ISSUE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697730 ↗
• MalfunctionJun 19, 2018Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT A TUBE CAME OUT OF A STOMA SITE FOLLOWING THE REMOVAL OF GASTROPEXY SUTURES SIX DAYS POST PLACEMENT. THE TUBE WAS REPLACED BY THE GASTROINTESTINAL NURSE, WITH NO ISSUES NOTED WITH THE BALLOON AT THE TIME OF REINSERTION. THE BALLOON INFLATION POTENTIALLY LED TO THE STOMACH WALL BEING PUSHED FROM THE ABDOMINAL WALL WITH GASTRIC CONTENTS SEEPING INTO THE PERITONEUM. AN EMERGENCY LAPAROTOMY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE BUTTON WAS INITIALLY PLACED BY A DIFFERENT DOCTOR. IT WAS PLACED BY SECURING SUTURES THROUGH THE STOMACH TO SECURE. WHEN THE SUTURES WERE REMOVED BY THE CURRENT PHYSICIAN, THE TUBE POPPED OUT WITHOUT BEING MANIPULATED 10 MINUTES LATER IN THE GI CLINIC. IT BELIEVED THAT SOMEONE ALTERED THE BALLOON BECAUSE IT HAD BEEN IN PLACE FOR ONLY SIX DAYS AND WAS CHECKED BEFOREHAND TO FIND NO OBVIOUS LEAKS. ATTEMPTED BUTTON REPLACEMENT WAS PERFORMED BY THE GI NURSE AND THIS ACTION PUSHED THE STOMACH WALL AWAY, WHICH CAUSED SOME LEAKING OF GASTRIC CONTENTS INTO THE PERITONEUM. THE PATIENT HAD TO GO BACK IN FOR A FULL EMERGENT LAPAROTOMY AND OPEN STAMM DUE TO THIS. NO FURTHER INFORMATION WAS RECEIVED SURROUNDING THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7617801 ↗