AVANOS 94868Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant
Data updated Oct 16, 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 00350770948683), received between Jul 13, 2023 and Jul 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- 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.
MalfunctionJul 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE "CHILD'S FEEDING TUBE BALLOON IS 'LEAKING' FROM THE GASTRIC PORT AND AROUND THE STOMA SITE. CHILD HAS HAD FEEDING TUBE FOR OVER 21 YEARS, EXPERIENCING SKIN BREAKDOWN AND IRRITATION. ANTIBIOTIC OINTMENT AND GAUZE BEING UTILIZED, CHILD WAS ALSO ON AN ANTIBIOTIC. HAS NOT BEEN RE-SIZED RECENTLY" FOR A NEW GASTROSTOMY TUBE.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17318828 ↗
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-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
- NutraGlide Nasal Feeding Tube ENFT-06055-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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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