Halyard 94821Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651948219), received between Aug 17, 2017 and Jul 12, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• InjuryJul 12, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DEVICE'S BALLOON FAILED SOON AFTER INITIAL PLACEMENT, LEADING TO THE PATIENT DEVELOPING PERITONITIS AND REQUIRED SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Peritonitis

  MAUDE report 7681133 ↗
• DeathAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED 17 AUG 2017, THE HOSPITAL PHARMACIST COULD NOT CONFIRM THE HOSPITAL'S PRACTICES DUE TO HOW MUCH TIME HAD PASSED SINCE THE REPORTED EVENT. THE PHARMACIST ALSO REPORTED THAT "THE ENTERAL FEEDING ON GASTROSTOMY BEGAN AFTER THE TUBE WAS PLACED. THE PATIENT NEVER HAD A FEEDING TUBE BEFORE. THE PATIENT LOST (B)(6) OVER 6 MONTHS WITH PROGRESSIVE DYSPHAGIA IN A CARCINOMA OF THE MIDDLE ESOPHAGUS. THE DEVICE WAS PLACED AT LEFT HYPOCHONDRIUM. THE PATIENT HAD A MEDIAN LAPAROTOMY. THERE IS A RELEASE OF THE GASTROSTOMY WHOSE BALLOON IS NOT INFLATED." 7 ML OF FLUID WAS REMOVED FROM THE BALLOON PRIOR TO REMOVAL, AND NO DEFECT WAS REPORTED REGARDING THE TUBE OR THE BALLOON.

  Patient problems: Death; Peritonitis

  MAUDE report 6802031 ↗