Halyard 94782Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651947823), received between Mar 22, 2017 and Sep 20, 2018 — classified as 1 death, 1 injury.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORT (B)(4) WAS RECEIVED THAT STATED: PATIENT UNDERWENT A SURGICAL PROCEDURE EARLIER THIS MONTH TO PLACE A GASTROSTOMY TUBE. BALLOON ON DEVICE WAS SUCCESSFULLY TESTED PRIOR TO INSERTING INTO PATIENT. THE DEVICE WAS INSERTED BY THE SURGEON AND THE BALLOON WAS INFLATED ONCE IN THE PATIENT AND WAS NOTED TO BE SUCCESSFULLY INFLATED. PATIENT BECAME UNSTABLE OVERNIGHT AND HAD A CT PULMONARY ANGIOGRAPHY (CTPA) IN THE MORNING THE NEXT DAY. PATIENT HAD A PULMONARY EMBOLUS AND ALSO NOTED TO HAVE A LARGE AMOUNT OF INTRAPERITONEAL FREE AIR. THE PATIENT WAS TAKEN QUICKLY BACK TO THE QR TO ASSESS THE ABDOMEN. WHEN THE PATIENT WAS TRANSFERRED OFF THE BED, THE GASTRONOMY TUBE FELL OUT OF THE PATIENT AND THE BALLOON WAS DEFLATED. THE PATIENT WAS NOTED TO HAVE TUBE FEEDING IN THE ABDOMEN. THE PATIENT REQUIRED AN ICU ADMISSION FOLLOWING SURGERY."

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 7895209 ↗
• DeathMar 22, 2017Break; Break

  IT WAS REPORTED BY THE CAREGIVER THAT THE PATIENT DIED (B)(6) 2016. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT THE END OF (B)(6) 2016 FROM THE EMERGENCY ROOM WITH DIAPHORESIS AND A DISTENDED ABDOMEN. THE HOSPITAL PLACED A 22 FRENCH MIC GASTROSTOMY TUBE IN THE PATIENT. TWENTY-FOUR HOURS AFTER PLACEMENT, THE CAREGIVER NOTICED THE STOMA SITE WAS INCREASING IN SIZE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL AT THE REQUEST OF THE CAREGIVER. DURING TRANSPORT, THE PATIENT HAD EXCESSIVE LEAKING OF GASTRIC CONTENTS AND BLOOD. UPON ARRIVAL AT THE HOSPITAL, THE 22 FRENCH WAS EXPELLED BECAUSE OF A BALLOON BREAK. THE MIC GASTROSTOMY TUBE WAS REPLACED WITH AN 18 FRENCH MIC GASTROSTOMY TUBE. THE CAREGIVER STATED THAT WITHIN 24-HOURS, THE 18 FRENCH MIC GASTROSTOMY TUBE WAS ALSO EXPELLED AND APPEARED INTACT. THE CAREGIVER STATED THE PATIENT EXPERIENCED MULTIPLE SURGERIES, BOWEL LEAKAGE, AND A STOMA SITE FISTULA, 8-INCHES IN DIAMETER. THE PATIENT ALSO RECEIVED BLOOD TRANSFUSIONS DURING THE HOSPITAL STAY, AND WAS RELEASED HOME ON A VENTILATOR. THE PATIENT WAS AT HOME FOR EIGHT TO NINE DAYS AND EXPERIENCED A PERFORATED BOWEL AND WAS RE-ADMITTED TO THE HOSPITAL. ADDITIONAL INFORMATION WAS RE

  Patient problems: Abdominal Distention; Bowel Perforation; Death; Diaphoresis; No Code Available

  MAUDE report 6424813 ↗