Halyard 94975Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651949759), received between May 18, 2018 and Mar 5, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Deflation Problem” (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. 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.

• DeathMar 5, 2020Deflation Problem; Malposition of Device; Deflation Problem; Malposition of Device

  IT WAS REPORTED VIA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4): PATIENT HAD J TUBE PLACEMENT. FLUSH OF D5 30CC Q 6 HOURS TO FOLLOW. PATIENT WITH ACUTE RESPIRATORY DISTRESS AND FAILURE DUE TO ASPIRATION PNEUMONIA AND TRANSFER TO THE TICU 2 DAYS LATER. ON CT WAS FOUND TO HAVE SBO AT SITE OF J TUBE INSERTION. WITH RISING LACTIC ACID AND WORSENING STATUS, PATIENT WENT TO OR 2 DAYS LATER. FOUND TO HAVE BALLOON DILATED GREATER THAN 100CC CAUSING BOWEL NECROSIS OF SURROUNDING AREA. UNABLE TO ASPIRATED FLUID THROUGH DURING THE OR" (SBO=SMALL BOWEL OBSTRUCTION). OR FINDINGS J-TUBE BALLOON WAS THOUGHT TO BE FULLY DEFLATED TWO DAYS PRIOR TO THE OR HOWEVER INTRAOPERATIVELY THE BALLOON WAS FOUND TO BE HYPERINFLATED AND TENSE (SIZE OF A LARGE LEMON) OBSTRUCTING THE LUMEN AND STRETCHING BOWEL WELL, CAUSING CONTUSION ON ONE SIDE OF THE BOWEL ALONG THE LINE OF MAXIMUM TENSION. THE BALLOON PORT WAS NONFUNCTIONAL (UNABLE TO ASPIRATE THE FLUID OUT USING DURING PER USUAL FASHION) AND THE SIDE PORT WAS CUT USING MAYO SCISSORS TO RELEASE THE FLUID FROM THE BALLOON (~ 100CC). OLD J-TUBE THEN REMOVED (20FR (0200-20) LOT AA9028N05) AND A NEW ONE REPLACED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MEDICATIO

  Patient problems: Death; Necrosis; No Code Available; Obstruction/Occlusion

  MAUDE report 9792301 ↗
• InjuryMay 18, 2018Partial Blockage; Deflation Problem; Partial Blockage; Deflation Problem

  IT WAS REPORTED THAT A BOWEL PERFORATION OCCURRED AFTER A NURSE USED A NEEDLE TO BURST A FEEDING TUBE BALLOON IN THE PATIENT. THE PATIENT HAS DUCHENNE'S DISEASE AND IS ON VENTILATOR. THE NURSE WAS ATTEMPTING TO REMOVE THE FEEDING TUBE, AS IT WAS "GETTING VACCUUM." THE TUBE WAS ALSO ALLEGEDLY CLOTTING SO IT WAS DIFFICULT TO GET A WIRE IN. THE NURSE WAS UNABLE TO GET WATER OUT OF THE BALLOON, SO THE NURSE FIRST ATTEMPTED TO PUT MORE WATER INTO THE BALLOON TO BURST IT, BUT THIS WAS PAINFUL TO THE PATIENT. THEN THE NEEDLE WAS USED BY THE NURSE TO PERFORATE THE BALLOON. THE PATIENT ENDED UP CRITICALLY ILL IN THE INTENSIVE CARE UNIT WITH ABDOMINAL SEPSIS FROM A BOWEL PERFORATION. PER ADDITIONAL INFORMATION RECEIVED 10 MAY 2018, THE PATIENT HAS PREVIOUSLY BEEN TREATED WITH AMFOTERICINE B SUSPENSION TWICE PER DAY FOR CANDIDA GLABRATA. THE PATIENT DOES NOT RECEIVE MCT OIL. FEEDING AND MEDICATION ARE DONE IN THE JEJUNUM (MACROGOL/SALT POWDER VOOR LIQUID 10MG, 1 TIME PER DAY, FUROSEMIDE, ACETYLSALICYL EFFERVESCENT TABLET, PARACETAMOL TABLETS). AT THE TIME THE CHANGING FROM THE TUBES GOT DIFFICULT THE PATIENT ALSO USED ESOMEPRAZOL GRAN FOR SUSPENSION 10 MG AND PERINDOPRIL. THIS WAS STOPPED AFT

  Patient problems: Bowel Perforation; Sepsis

  MAUDE report 7528175 ↗