AVANOS 95480Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770954806), received between Oct 13, 2022 and May 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 16, 2024Open, Classified

   MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.

   Z-1187-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionMay 6, 2025Migration; Migration

  IT WAS REPORTED, "LAST YEAR THE TUBE TRIED TO COME OUT OF HER THROAT AFTER BALLOON RUPTURE.¿

  Patient problems: Insufficient Information

  MAUDE report 21970646 ↗
• InjuryOct 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT¿S SPOUSE REPORTED THE GASTROINTESTINAL (GJ) TUBE WAS INITIALLY PLACED ON MONDAY (B)(6) 2022, THE PATIENT DEVELOPED DISCOMFORT THAT EVENING [AT] 10-11 PM. THE SPOUSE SPOKE TO RADIOLOGY AND WAS ADVISED TO GO TO THE HOSPITAL. THE PATIENT RETURNED TO THE HOSPITAL ON TUESDAY MORNING AT 3 AM AND A COMPUTED TOMOGRAPHY SCAN (CAT) SCAN CONFIRMED THE GJ TUBE WAS DISLODGED. IT WAS ADDITIONALLY REPORTED, THE BALLOON/GJ TUBE DISLODGED INTO THE PYLORUS, BLOCKED THE STOMACH, AND CAUSED FLUID TO BACK UP; THE PATIENT REPORTEDLY SPIT UP BILE. THE GJ TUBE WAS REPOSITIONED AND SECURED IN PLACE WITH SILK SUTURES AND THE PATIENT WAS KEPT FOR OBSERVATION OVERNIGHT AND DISCHARGED THE FOLLOWING DAY. THE SPOUSE CONFIRMED THERE HAVE BEEN NO FURTHER COMPLICATIONS.

  Patient problems: Discomfort; Vomiting

  MAUDE report 15612039 ↗
• InjuryOct 13, 2022Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE "PATIENT'S SON REPORTS THAT HIS FATHER'S G TUBE APPEARS TO BE NOT FUNCTIONING PROPERLY. STATES HE IS ABLE TO FLUSH THE G-TUBE BUT FLUSHING CONTENTS FLOW BACK OUT OF TUBING. STATES THIS HAS BEEN HAPPENING FOR ABOUT A WEEK, WILL FOLLOW UP WITH PROCEDURALIST." THE 'PATIENT¿S SON CONFIRMED GASTRIC FLUID AND WATER BACKFLOWS FROM PEG TUBE ISSUE BEGAN RIGHT BEFORE (B)(6) 2022. PATIENT¿S SON STATED PATIENT PULLED AT PEG TUBE A LITTLE BIT OUT RECENTLY UP TO WHERE ITS MARKED #2 ON THE TUBING... PATIENT'S SON AS WELL REPORTED PATIENT HAD POSSIBLE INFECTION AT THE STOMA SITE OR THE 'HOLE' AREA. PATIENT'S SON STATED THE STOMA SITE COMPLICATION OCCURRED FEW TIMES SINCE REPLACEMENT IN (B)(6) 2022 A COUPLE OF TIMES IN (B)(6) 2022 AND THEY WOULD FOLLOW UP WITH [THE HEALTHCARE PROVIDER]. PATIENT¿S SON STATED BECAUSE PATIENT EXPERIENCED BLOOD, REDNESS AND A WHITE DRAINAGE AT STOMA SITE AND WAS TREATED WITH SILVER NITRATE MEDICATION. PATIENT'S SON STATED EACH TIME IT RECOVERED AND NO ORAL OR INTRAVENOUS ANTIBIOTICS WERE PRESCRIBED." REPORTER CLARIFIED PATIENT DID NOT HAVE A REPLACEMENT IN (B)(6) 2022 BUT CONTRAST WAS USED TO CHECK PLACEMENT, DUOPA TUBING WAS ASSESSED AT THAT TIME A

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Purulent Discharge; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 15601462 ↗