Halyard 95664Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651956641), received between Mar 31, 2017 and Mar 31, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).

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

• MalfunctionMar 31, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS INVOLVING ONE PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2017-00040 FOR THE FIRST REPORT. REFER TO 9611594-2017-00041 FOR THE SECOND REPORT. IT WAS REPORTED BY THE CAREGIVER THAT; THE PATIENT WAS TAKEN TO THE HOSPITAL THREE TIMES DUE TO THE JEJUNAL PORTION OF THE TRANSGASTRIC-JEJUNAL MICKEY FEEDING TUBE MIGRATING BACK INTO THE STOMACH. THE CAREGIVER STATED, THE TUBE WAS REPLACED ON (B)(6) 2017. THE CAREGIVER STATED IN EACH INSTANCE A FLUOROSCOPY WAS PERFORMED AND THE SAME SIZE TUBE WAS PLACED. THE CAREGIVER STATED THE PATIENT EXPERIENCED EMESIS REGULARLY AND HAD A "FLARE UP" THE PREVIOUS WEEK AND WAS IN THE HOSPITAL TO ADDRESS THE ISSUE. THE PATIENT WAS SENT HOME ONCE THE MEDICAL "FLARE UP" WAS MANAGED, BUT IS CURRENTLY EXPERIENCING ISSUES WITH THE TUBE. THE PATIENT RECEIVES NUTRITION THROUGH THE JEJUNAL PORTION OF THE TUBE AND HAS LOST 10-12 POUNDS RECENTLY. THE CAREGIVER STATED THE PATIENT IS CURRENTLY TAKING MIRALAX DAILY, WITH NO CHANGES IN THE FORMULA. THE BALLOON IS FILLED WITH 8 ML OF STERILE WATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449048 ↗
• MalfunctionMar 31, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS INVOLVING ONE PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2017-00041 FOR THE SECOND REPORT. REFER TO 9611594-2017-00042 FOR THE THIRD REPORT. IT WAS REPORTED BY THE CAREGIVER THAT; THE PATIENT WAS TAKEN TO THE HOSPITAL THREE TIMES DUE TO THE JEJUNAL PORTION OF THE TRANSGASTRIC-JEJUNAL MIC KEY FEEDING TUBE MIGRATING BACK INTO THE STOMACH. THE CAREGIVER STATED, THE TUBE WAS REPLACED ON (B)(6) 2017. THE CAREGIVER STATED IN EACH INSTANCE A FLUOROSCOPY WAS PERFORMED AND THE SAME SIZE TUBE WAS PLACED. THE CAREGIVER STATED THE PATIENT EXPERIENCED EMESIS REGULARLY AND HAD A "FLARE UP" THE PREVIOUS WEEK AND WAS IN THE HOSPITAL TO ADDRESS THE ISSUE. THE PATIENT WAS SENT HOME ONCE THE MEDICAL "FLARE UP" WAS MANAGED, BUT IS CURRENTLY EXPERIENCING ISSUES WITH THE TUBE. THE PATIENT RECEIVES NUTRITION THROUGH THE JEJUNAL PORTION OF THE TUBE AND HAS LOST 10-12 POUNDS RECENTLY. THE CAREGIVER STATED THE PATIENT IS CURRENTLY TAKING MIRALAX DAILY, WITH NO CHANGES IN THE FORMULA. THE BALLOON IS FILLED WITH 8 ML OF STERILE WATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449047 ↗
• MalfunctionMar 31, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS INVOLVING ONE PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2017-00040 FOR THE FIRST REPORT. REFER TO 9611594-2017-00042 FOR THE THIRD REPORT. IT WAS REPORTED BY THE CAREGIVER THAT; THE PATIENT WAS TAKEN TO THE HOSPITAL THREE TIMES DUE TO THE JEJUNAL PORTION OF THE TRANSGASTRIC-JEJUNAL MIC KEY FEEDING TUBE MIGRATING BACK INTO THE STOMACH. THE CAREGIVER STATED, THE TUBE WAS REPLACED ON (B)(6) 2017. THE CAREGIVER STATED IN EACH INSTANCE A FLUOROSCOPY WAS PERFORMED AND THE SAME SIZE TUBE WAS PLACED. THE CAREGIVER STATED THE PATIENT EXPERIENCED EMESIS REGULARLY AND HAD A "FLARE UP" THE PREVIOUS WEEK AND WAS IN THE HOSPITAL TO ADDRESS THE ISSUE. THE PATIENT WAS SENT HOME ONCE THE MEDICAL "FLARE UP" WAS MANAGED, BUT IS CURRENTLY EXPERIENCING ISSUES WITH THE TUBE. THE PATIENT RECEIVES NUTRITION THROUGH THE JEJUNAL PORTION OF THE TUBE AND HAS LOST 10-12 POUNDS RECENTLY. THE CAREGIVER STATED THE PATIENT IS CURRENTLY TAKING MIRALAX DAILY, WITH NO CHANGES IN THE FORMULA. THE BALLOON IS FILLED WITH 8 ML OF STERILE WATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449045 ↗