Halyard 46082Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651460827), received between Feb 20, 2023 and Jun 3, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Leak/Splash

  IT WAS REPORTED, "THERE WAS A LEAK FROM NG TUBE DURING FIRST TIME ADMINISTRATION." NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 25382336 ↗
• InjuryNov 3, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED INSERTION OF NASOGASTRIC TUBE (NG) TUBE BY PHYSICIAN DID NOT WORK. "THE TUBE DAMAGED THE PATIENT'S GASTRIC WALL SO INSERTION OF NG TUBE WAS STOPPED. THERE WAS MEDICAL INTERVENTION."

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18066127 ↗
• MalfunctionFeb 27, 2023Break; Break

  "IT WAS REPORTED THE "BOLUS PLUG DETACHED AND IT LEFT IN THE PATIENT'S STOMACH." THERE WAS NO NOTATION OF MEDICAL INTERVENTION TO RETRIEVE DISTAL PORTION OF THE TUBE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 STATING THE "TUBE WAS USED ABOUT 1-MONTH. THE HOSPITAL FOUND THE DETACHMENT WHEN THE TUBE WAS REMOVED BECAUSE THEY COULD NOT FEED/FLOW MEDICINE. WHEN THEY REVIEWED IMAGES TAKEN ON (B)(6) 2023, THE DISTAL BOLUS PLUG WAS DETACHED ALREADY BUT NO THE IMAGES 2-WEEKS AGO. THE HOSPITAL SAID THEY FLUSH THE TUBE IN EACH TIME OF THE FEEDING."

  Patient problems: Foreign Body In Patient

  MAUDE report 16450055 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED " WHEN INSERTING NG TUBE, THE DISTAL END OF THE TUBE REACHED A PATIENT'S LUNG AND A PNEUMOTHORAX OCCURRED. IT WAS ALSO REPORTED THAT THERE WAS A PROBLEM DURING THE PROCEDURE." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 16404547 ↗