AVANOS 40-9558Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770460543), received between Mar 25, 2024 and Dec 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 30, 2025Stretched; Stretched

  IT WAS REPORTED, ¿WE HAD A PATIENT COME IN TODAY WITH AN AVANOS 8FR 140CM ND [NASODUODENAL] TUBE THAT WAS PLACED (B)(6) 2025 THAT WAS FUNCTIONING FINE UNTIL ABOUT A WEEK AGO.¿ PICTURE PROVIDED SHOWS THAT THE TUBE HAS BALLOONED. PER ADDITIONAL INFORMATION RECEIVED ON 12DEC2025, ¿WE ARE UNAWARE OF ANY CLOGGING ISSUES, IT WAS MORE A (EVERY TIME SHE USED IT THERE WAS CHEST DISCOMFORT ISSUE). PATIENT WAS EXPERIENCING CHEST PAIN WITH FEEDS, X-RAY CONFIRMED TUBE PLACEMENT, BUT CHEST PAIN STILL PERSISTED, SO A FLUOROSCOPY TUBE CHECK WAS PERFORMED TO CONFIRM FUNCTION AND PLACEMENT (PLACEMENT IN THE DUODENUM WAS CORRECT). PATIENT UNDERWENT FLUOROSCOPIC X-RAY BUT NOTHING SURGICAL WAS PERFORMED. PATIENT HAS NEW TUBE IN PLACE AND IS DOING FINE.¿

  Patient problems: Chest Pain

  MAUDE report 23927499 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED AND MORNING CHEST X-RAY NOTED THE PATIENT'S FEEDING TUBE APPEARED TO HAVE BROKEN INSIDE THE PATIENT'S STOMACH. THE PHYSICIAN ORDERED FOR THE TUBE TO BE REMOVED. THE END OF THE TUBE APPEARED BROKEN. A REPEAT KIDNEY, URETER, AND BLADDER (KUB) X-RAY PERFORMED, AND A PIECE OF THE TUBE REMAINED IN THE PATIENT' STOMACH/DUODENUM. THE PATIENT WAS NOT STABLE ENOUGH TO HAVE A PROCEDURE TO HAVE THIS PIECE REMOVED. ADDITIONAL INFORMATION RECEIVED 10-JAN-2025 STATED THE TUBE WAS PLACED (B)(6)2024. THE TUBE WAS BEING USED FOR CONTINUOUS FEEDS, AND MEDICATIONS. THE FORMULA BEING USED WAS NEOCATE SPLASH, THOUGH IT HAD BEEN HELD FOR A FEW DAYS PRIOR TO THE EVENT. BOTH ORAL AND CRUSHED MEDICATIONS WERE USED ON THE TUBE. IT IS UNKNOWN HOW OFTEN THE TUBE WAS FLUSHED. THE REPORTING CLINICIAN "NEVER FLUSHED THE TUBE PERSONALLY, BUT OUR PROTOCOL IS TO MANUALLY FLUSH. IT WAS REPORTED OVERNIGHT THERE WAS A CLOG IN THE TUBE." WARM WATER WAS USED FOR FLUSHING THE TUBE. THE PATIENT'S STATUS IS EXTREMELY CRITICALLY ILL, UNRELATED TO THE RETAINED FEEDING TUBE. IT IS UNKNOWN "WHO PLACED THE TUBE, BUT THE FEEDING TUBE WAS IN PLACE FOR A FEW WEEKS WITHOUT ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21283196 ↗
• MalfunctionMar 25, 2024Crack; Material Rupture; Stretched; Crack; Material Rupture; Stretched

  IT WAS REPORTED, THAT ON (B)(6) 2024, A NASOJEJUNAL (NJ) TUBE WAS PLACED ON PATIENT. ON (B)(6) 2024, THE PATIENT STARTED VOMITING. PATIENT BROUGHT IN TO REPLACE NJ TUBE. WHILE REPLACING NJ, IT WAS NOTICED THAT THE NJ HAD A CRACK IN IT. THE PART THAT HAD THE CRACK WOULD HAVE BEEN IN THE PATIENT'S STOMACH. TUBE REMOVED AND NEW ONE WAS PLACED WITHOUT INCIDENT. THE PATIENT ENDURED MORE RADIATION TO PLACE THE NEW TUBE, BUT NO PATIENT INJURY OCCURRED.

  Patient problems: Vomiting

  MAUDE report 18969926 ↗