Halyard 94845Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651948455), received between Feb 2, 2018 and Apr 27, 2018 — classified as 2 injuries, 1 malfunction.

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

• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A SUSPECTED ALLERGY TO SILICONE. THE GASTROSTOMY TUBE WAS CHANGED FOR ANOTHER SIZE DEVICE. THE PROTECTIVE DRESSING WAS KEPT DRY IN AN EFFORT TO PREVENT GRANULATION TISSUE GROWTH. IN (B)(6) 2018, THE PATIENT HAD THE BIGGEST GRANULATION GROWTH OVER THE ENTIRE STOMA SITE. THE PATIENT WAS HOSPITALIZED FOR 22-DAYS AND RECEIVED A SERIES OF ANTIBIOTICS. THE PATIENT HAD BEEN VOMITING. THE FAMILY MEMBER IS NOW USING SILVER DRESSING TO STOP THE GRANULATION BUT THE PATIENT REMAINS IN PAIN. A DEBRIDEMENT SURGICAL PROCEDURE WAS PERFORMED AND THE DEVICE WAS CHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cellulitis; Hypersensitivity/Allergic reaction; Pain; Vomiting

  MAUDE report 7470115 ↗
• InjuryApr 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A SUSPECTED ALLERGY TO SILICONE. THE GASTROSTOMY TUBE WAS CHANGED IN (B)(6) 2017. GRANULATION TISSUE AND A BLOODY STOMA WERE NOTED. THE PATIENT'S FEEDING SOLUTION WAS CHANGED. THE PATIENT RECEIVED TOPICAL GENTAMICIN, ANTIBIOTICS AND ANTI-INFLAMMATORY MEDICINE. FROM (B)(6) 2017 THROUGH (B)(6) 2018 THE CELLULITIS WAS GETTING WORSE. SUBSEQUENTLY, THE GASTROSTOMY TUBE WAS CHANGED AGAIN.

  Patient problems: Cellulitis; Hypersensitivity/Allergic reaction

  MAUDE report 7469903 ↗
• MalfunctionFeb 2, 2018Break; Break

  IT WAS REPORTED THAT DURING REPLACEMENT OF THE DEVICE THE TUBE BROKE IN HALF. THE PATIENT RETAINED ONE-HALF OF THE DEVICE WHICH WAS FOUND IN THE PATIENT'S CLOTHES, THE OTHER HALF MIGRATED WITHIN THE PATIENT'S STOMACH. IT HAD BEEN REPORTED THAT THE PATIENT HAD BEEN SCRATCHING THE STOMA SITE AND NOT PULLING AT THE TUBE. THE STOMA SITE HAD NOT BEEN CULTURED. IT IS UNSURE IF THE PATIENT WAS MEASURED WITH A STOMA MEASURING DEVICE (SMD). A 5 CC OF BOTTLED WATER WAS USED TO THE FILL THE BALLOON. THERE WERE NO CHANGES IN FOOD OR MEDICATION. THERE WAS NO REPORTED INJURY AND NO MEDICAL INTERVENTION AT THAT TIME. THE STOMA SITE DID NOT CLOSE AND ANOTHER GASTROSTOMY TUBE WAS PLACED. THE FAMILY MEMBER WAS ADVISED TO CONTACT THE PHYSICIAN.

  Patient problems: Foreign Body In Patient; Itching Sensation

  MAUDE report 7235654 ↗