AVANOS 45819Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770458199), received between Jun 26, 2020 and Jun 26, 2020 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED WHEN THE NURSE REMOVED THE DEVICE THE BOTTOM PART OF THE NASOGASTRIC (NG) TUBE BROKE OFF AND REMAINED IN THE PATIENT'S GASTROINTESTINAL (GI) TRACT. THE DEVICE WAS PLACED IN THE INTERVENTIONAL RADIOLOGY (IR) DEPARTMENT. ADDITIONAL INFORMATION RECEIVED ON 04-JUN-2020 STATED, "I AM GUESSING WE USED THIS CORTRAK TUBE IN IR BECAUSE WE LIKELY PLACED IT GASTRIC AND THEY WANTED IT ADVANCED TO POST-PYLORIC (PP)." ADDITIONAL INFORMATION RECEIVED ON 15-JUN-2020 STATED THE TUBE FEEDING WAS TOLERATED AND THE FEEDING TUBE WAS CHANGED OUT AS PP. THE DEVICE CLOGGED AND COULD NOT BE UNCLOGGED. WHEN THE DEVICE WAS REMOVED IT WAS NOTED THAT THE END OF THE FEEDING TUBE WAS MISSING, AND THE PHYSICIAN WAS PAGED. A LARGE BORE OROGASTRIC (OG) TUBE WAS PLACED. THE PATIENT'S BLOOD SUGAR DROPPED TO 66MG/DL WHEN THE FEEDINGS STOPPED, AND THE PATIENT WAS GIVEN 25ML D50 WHICH RESOLVED THE HYPOGLYCEMIA. THE FEEDINGS WERE RESUMED USING THE LARGE BORE OG TUBE. THE INITIAL NG TUBE WAS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020. THE CLINICIANS ASSUMED THE BROKEN NG TUBE PART WAS PASSED NATURALLY AND WAS NOT OBSERVED IN THE PATIENT'S STOOL. THE PATIENT WAS RECEIVING LACTULOSE AND PASSING STOOLS.

  Patient problems: Foreign Body In Patient; Hypoglycemia

  MAUDE report 10200532 ↗