AVANOS 94888Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770948881), received between Nov 1, 2023 and Dec 5, 2023 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Erythema1
- Fungal Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, THE NURSE NOTICED EXCORIATION AROUND PATIENT¿S STOMA SITE. THEY USED PRODUCTS PATIENT ALREADY HAD TO HELP AND KEEP AREA DRY SUCH AS NYSTATIN POWDER, STOMA ADHESIVE POWDER, AND GAUZE. NO INJURY REPORTED.
Patient problems: Erythema
MAUDE report 18266982 ↗InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, ¿SERIOUS REDNESS AND SKIN BURNING OCCURRED. A LAB CULTURE WAS TAKEN. CULTURE SHOWED MODERATE GROWTH OF YEAST CANDIDA. PACKAGING WAS VERIFIED INTACT. FILTERED WATER WAS USED 5.0ML. DUE TO THE SAMPLE BEING PROCESSED IN LAB IT WAS DISPOSED AS BIOHAZARDOUS UNDER SUSPICION OF BACTERIAL AND OR VIRAL CONTAMINATION. IT WAS HELD DURING THE TIME THE CULTURES WERE PROCESSING HOWEVER THE CULTURES WERE FINISHED AS OF THIS MORNING AND THE PHYSICIAN TEAM DID NOT CHECK THE ¿RETURN SAMPLES TO CLINIC¿ BOX ON THE LAB FORMS. THE SAMPLE CANNOT BE RETRIEVED HOWEVER THE LAB REPORT CAN BE PROVIDED. ANTIFUNGAL INTERVENTION WAS REQUIRED. NO HOSPITAL INVOLVEMENT OUTPATIENT CLINIC ¿ DERMATOLOGY. NYSTATIN 100,000U CREAM FOR 3 WEEKS TO THE PEG SITE TO ERADICATE ANY YEAST ORGANISMS. [THE PATIENT IS] STABLE CONDITION BEING MANAGED BY HOME INTERVENTION WITH TELEHEALTH SERVICING APPROX. WEEKLY.¿
Patient problems: Fungal Infection
MAUDE report 18049536 ↗
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
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.