AVANOS 94845Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770948454), received between Sep 6, 2023 and Nov 13, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Deflation Problem1
Patient problems
- Skin Inflammation/ Irritation2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THERE WAS A DEFECTIVE MIC-KEY GASTROSTOMY TUBE. THE ISSUE PERTAINED TO A MALFUNCTIONING BALLOON INFLATION PORT THAT WAS STUCK, RENDERING THE CAREGIVER UNABLE TO DEFLATE THE INTERNAL BALLOON. PER THE PATIENT'S MOTHER, ON (B)(6) 2025, THE PATIENT WAS TAKEN TO THE...HOSPITAL EMERGENCY ROOM DUE TO THE INABILITY TO DEFLATE THE BALLOON AND REMOVE THE TUBE. A PEDIATRIC GASTROENTEROLOGIST WAS CONSULTED AND ATTEMPTED REMOVAL BUT WAS ALSO UNSUCCESSFUL. DIAGNOSTIC IMAGING (X-RAY) CONFIRMED THAT THE BALLOON REMAINED INFLATED IN THE STOMACH. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING ROOM, PLACED UNDER GENERAL ANESTHESIA, AND UNDERWENT AN ENDOSCOPIC PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS PUNCTURED ENDOSCOPICALLY, AND ALL RESIDUAL BALLOON FRAGMENTS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO POSTOPERATIVE RECOVERY FOLLOWING THE PROCEDURE." THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543984 ↗InjurySep 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED, THE MICKEY TUBE LEAKED AND THE PATIENT EXPERIENCED STOMA REDNESS FROM THE GASTRIC JUICES. THE STOMA WAS TREATED WITH OVER-THE-COUNTER CREAMS FOR SEVERAL MONTHS. THE PATIENT¿S PHYSICIAN WAS NOTIFIED IN JUNE OR JULY AND THE PATIENT WAS PRESCRIBED "RILEY'S BUTT CREAM." THE PRESCRIPTION CREAM HEALED THE STOMA SITE QUICKLY.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17831015 ↗InjurySep 6, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED, THE FEEDING TUBE IS LEAKING FROM UNDERNEATH THE PORT. PER ADDITIONAL INFORMATION RECEIVED ON 14AUG2023, THE STOMA SITE HAS SOME IRRITATION WHICH WAS BEING TREATED WITH FUCIDIN CREAM. NO INJURY REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17694310 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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