AVANOS 95459Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Jejunal Feeding Tube Kit · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770954592), received between May 19, 2023 and May 19, 2023 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Infection1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S STOMA SITE IRRITATION WAS CAUSED BY "LEAKAGE OF GASTRIC SECRETIONS BETWEEN STOMA SITE AND MICKEY J FEEDING TUBE. STOMA SITE HAS BEEN RED, IRRITATED AND PAINFUL FOR THE PAST YEAR. DOCTOR'S HAVE DECREASED THE LENGTH OF THE TUBE FROM A 3.0 TO A 2.0 IN THE PAST MONTH WITH NO IMPROVEMENT TO STOMA SITE LEAKAGE. NO CHANGE IN TUBE FRENCH SIZE. PATIENT DOES NOT KNOW HOW MUCH WATER IS IN THE BALLOON. NO SYRINGE AVAILABLE TO CHECK FLUID AMOUNT IN BALLOON. CURRENTLY [PATIENT] IS ON A 2-WEEK COURSE OF LEVOFLOXACIN, AND TOPICAL CLOTRIMAZOLE/BETAMETHASONE CREAM. DENIES ANY FEVER OR CHILLS."
Patient problems: Skin Infection; Skin Inflammation/ Irritation
MAUDE report 16961533 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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