Halyard 45758Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651457582), received between Jul 23, 2019 and Oct 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Break; Difficult to Remove

  AN ELDERLY FEMALE PATIENT WITH A HISTORY OF OBSTRUCTIVE LUNG DISEASE REQUIRED DOBHOFF FEEDING TUBE INSERTION PER PROTOCOL. UNABLE TO REMOVE GUIDEWIRE. THE END PLASTIC PIECE ON THE GUIDEWIRE BROKE OFF, SO THE ENTIRE TUBE HAD TO BE REMOVED AND REPLACED. TUBE AND PACKAGING WERE KEPT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213486 ↗
• MalfunctionJul 23, 2019Flushing Problem; Difficult to Remove

  SINCE A FEW MONTHS AGO, STAFF REPORTING ISSUES THAT AFTER FEEDING TUBE INSERTION AND X-RAY CONFIRMATION OF PLACEMENT, THE GUIDE WIRE IS UNABLE TO BE REMOVED. STAFF ALSO REPORTING THAT THEY ARE ABLE TO FLUSH TUBE PRIOR TO INSERTION BUT NOT AFTER INSERTION. NO CHANGE IN PRACTICE OR PROCESS. THIS HAS OCCURRED AT LEAST 10 TIMES, 7 THAT WE AREA ABLE TO CONFIRM WITH THE SAME LOT NUMBER. UPON INVESTIGATION, STAFF REPORTING 6-8 TIMES LAST MONTH THAT THEY EXPERIENCED DIFFICULTY, BUT THOUGHT IT WAS THEIR INSERTION TECHNIQUES. THIS HAS OCCURRED IN OUR HOSPITAL AND IN OUR LONG-TERM ACUTE CARE HOSPITAL (LTACH) UNIT. WE HAVE ABOUT 4 TUBES WITH PACKAGING THAT WE WILL BE RETURNING TO THE COMPANY. NO PATIENTS HAVE BEEN DIRECTLY INJURED IN THESE INCIDENTS: HOWEVER, THEY HAVE HAD TO HAVE THE TUBES REMOVED, REPLACED, HAVE ANOTHER X-RAY TO VERIFY PLACEMENT. THIS HAS CAUSED SOME DELAY TO INITIATION OF MEDICATIONS AND OR FEEDINGS, BUT AGAIN, NO HARM OR ADVERSE OUTCOME TO PATIENTS. WE REPORTED A SIMILAR EVENT ABOUT A YEAR AGO. THE DEVICE INVOLVED IN THIS REPORT WAS A HALYARD PRODUCT, NOT A MEDTRONIC PRODUCT AS PREVIOUSLY DESCRIBED. MANUFACTURER RESPONSE FOR TUBE, FEEDING, HALYARD (PER SITE REPORTER). THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815329 ↗