Halyard 95668Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651956689), received between Jun 30, 2017 and Mar 29, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (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.

• MalfunctionMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE GASTRO-JEJUNAL TUBE MIGRATED OUT OF PLACE. THE USER REPORTS RESOLVING THE ISSUE BY REPOSITIONING AND BY PLACING A 20FR 55CM OR THAT¿S WHAT SHE WAS TOLD. THE PATIENT KNEW THE 20FR IS OR WAS RIGHT BECAUSE IT WAS LABELED ON THE TUBE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018 STATED THE DEVICE WAS PLACED (B)(6) 2018. THE TUBE MIGRATED OUT OF THE PATIENT'S MOUTH AND THE PATIENT REPORTS PUSHING THE TUBE BACK IN THE MOUTH. THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7383246 ↗
• MalfunctionJun 30, 2017Migration or Expulsion of Device; Difficult To Position; Migration or Expulsion of Device; Difficult To Position

  IT WAS REPORTED BY THE CAREGIVER THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM BECAUSE THE JEJUNAL PORTION OF THE TRANSGASTRIC-JEJUNAL (GJ) FEEDING TUBE, MIGRATED INTO THE ESOPHAGUS ON (B)(6)2017. THE CAREGIVER STATED, THE ISSUE WAS RESOLVED BY THE PHYSICIAN REPLACING THE GJ TUBE WITH A G-TUBE. THE PHYSICIAN STATED THE GJ WAS ORIGINALLY PLACED TWO WEEKS AGO, EXACT DATE UNKNOWN. THE PHYSICIAN WAS UNABLE TO GET THE TUBE PAST THE DUODENUM. THE CAREGIVER STATED THE PATIENT PREVIOUSLY HAD A STANDARD IMPLANTED J-TUBE WHICH WORKED WITHOUT ISSUE, BUT PREFERRED THE AESTHETIC OF THE LOW-PROFILE TUBE. THE PATIENT IS CURRENTLY STABLE AND THE PHYSICIAN IS PURSUING VARIOUS J-TUBE OPTIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680659 ↗