AVANOS 42716Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770427164), received between Sep 20, 2019 and May 15, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Cross Reactivity; Cross Reactivity

  IT WAS REPORTED THE PATIENT "HAD A PSEUDOMONAS INFECTION AROUND STOMA SITE AND WAS HOSPITALIZED FOR TREATMENT. THE CARE GIVERS "ARE CONCERNED ABOUT REGROWTH ONCE ANTIBIOTICS ARE COMPLETE." THERE WAS NO REPORTED INJURY..

  Patient problems: Unspecified Infection

  MAUDE report 22032021 ↗
• MalfunctionOct 15, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED, PATIENT AT HOME WITH CAREGIVER AND HE WAS BEING MOVED FROM BED TO CHAIR. FEEDING SET GOT CAUGHT AND TUBE WAS REMOVED. REPORTER EXPECTED BALLOON TO HAVE COME OUT AS WELL, BUT THE DEVICE HAS SHEARED IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 20454373 ↗
• InjuryJul 31, 2024Cross Reactivity; Cross Reactivity

  IT WAS REPORTED, "PATIENT HAD ONGOING ISSUES WITH BLACK EXUDATE COMING OUT OF THE STOMA AND PAIN. ONGOING PROBLEMS WITH PAIN/DISCOMFORT/BLOATING/BLACK DISCHARGE AND BLEEDING. FREQUENT SWABS TAKEN - NO CURRENT INFECTION ISOLATED." CUSTOMER CONFIRMED, "THIS IS NOT A DEVICE ISSUE." ADDITIONAL INFORMATION RECEIVED ON 02-JUL-2024 STATED PARACETAMOL AND ANTIBIOTICS WERE USED TO TREAT STOMA. ADDITIONAL INFORMATION RECEIVED ON 03-JUL-2024 STATED THE DEVICE WAS INSERTED ON (B)(6) 2024.

  Patient problems: Discomfort; Pain; Purulent Discharge

  MAUDE report 19872416 ↗
• MalfunctionJan 24, 2023Break; Break

  IT WAS REPORTED, A LEAKAGE WAS NOTICED DURING FEEDING; IT WAS APPARENT THE PORT HAD DETACHED FROM THE BALLOON (THE BALLOON REMAINED INSIDE THE PATIENT¿S STOMACH). PER ADDITIONAL INFORMATION RECEIVED ON 13JAN2023, A PLUG WAS INSERTED, AND THE DOCTOR CONFIRMED THE PATIENT WILL EVENTUALLY PASS THE PIECE IN A BOWEL MOVEMENT; THE PATIENT WAS REPORTEDLY DOING WELL. PER ADDITIONAL INFORMATION RECEIVED ON 20JAN2023, THE PATIENT PASSED THE RETAINED PIECE THROUGH A BOWEL MOVEMENT. NO HARM OR INTERVENTIONS WERE TAKEN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16233341 ↗
• MalfunctionApr 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE INNER PART OF THE GASTROSTOMY BUTTON HAD SEPARATED FROM THE OUTER PORTION AND FELL INTO THE PATIENT'S STOMACH. THE TUBE HAD BEEN PLACED ON (B)(6) 2022. AN X-RAY WAS PRESCRIBED TO LOCATE THE BROKEN OFF PIECE OF THE TUBE AND TO CHECK FOR ANY INTESTINAL OCCLUSION. IN ADDITION THEY WILL BE MONITORING THE PATIENT FOR ABDOMINAL SIGNS. THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 14 APR 2022, THE PATIENT IS CURRENTLY DOING WELL. AN X RAY WAS PERFORMED AND THE PIECE OF DEVICE HAD PASSED NATURALLY. THE PATIENT DOES NOT REQUIRE ANY FURTHER FOLLOW UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 14115524 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER ADDITIONAL INFORMATION RECEIVED 25 SEP 2019, THE PATIENT IS CURRENTLY ON ANTIBIOTICS AND SKIN BARRIER CREAM FOR TREATMENT.

  Patient problems: No Code Available

  MAUDE report 9097238 ↗