Halyard 95842Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651958423), received between Apr 24, 2017 and Mar 29, 2018 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DEVICE WAS COILED/KNOTTED IN THE PATIENT'S STOMACH AND IT WAS ALSO SUSPECTED IT MAY BE PARTIALLY BURIED IN THE GASTROINTESTINAL TRACT. THIS CAUSED IMMEDIATE CAUSE FOR CONCERN FOR THE HEALTHCARE PROVIDERS. ADDITIONAL INFORMATION RECEIVED 14-MAR-2018 STATED ALL IS WELL. THE PATIENT WENT FOR A PROCEDURE AND THE TUBE WAS KNOTTED BUT NO LONGER BURIED. THE HEALTHCARE PROVIDERS WERE ABLE TO CUT EXTERNALLY AND REMOVE THE DEVICE ENDOSCOPICALLY WITH A SNARE. THE DEVICE WAS REPLACED WITH ANOTHER TRANSGASTRIC JEJUNAL TUBE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7383253 ↗
• InjuryApr 24, 2017Fracture; Leak/Splash; Migration or Expulsion of Device; Fracture; Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT FOLLOWING A WHIPPLES PROCEDURE ON (B)(6) 2017, A MIC* GJ TUBE WAS PLACED IN THE PATIENT. FOLLOWING THE SURGERY, AFTER SEVEN DAYS OF USE, THE TUBE FRACTURED JUST BELOW THE TRIPLE PORT, AFFECTING THE BALLOON CHANNEL AND CAUSING THE WATER TO LEAK OUT AND THE BALLOON TO FAIL. THE TUBE HAD SHIFTED FROM ITS ORIGINAL POSITION, REQUIRING A FOLLOW UP SURGICAL PROCEDURE TO REPAIR THE STOMACH ON (B)(6) 2017. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS KEPT ON TOTAL PARENTERAL NUTRITION. PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL DIETITIAN, THE HOSPITAL HAS ALLEGED THAT THE PATIENT DEVELOPED PERITONITIS AS A RESULT OF THE TUBE FAILING AND SHIFTING FROM ITS ORIGINAL POSITION. THE SURGERY THAT WAS PERFORMED TO REPAIR THE STOMACH WAS AN OMENTAL PATCH. AT THE TIME OF THIS CALL, THE PATIENT WAS STILL IN THE INTENSIVE CARE UNIT BUT WAS RECOVERING WELL. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Code Available; Peritonitis

  MAUDE report 6515988 ↗