AVANOS 47048Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastric-Jejunal Feeding Tube Kit Extension Sets · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770470481), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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.
Reports received per month
Recalls naming this device
- May 31, 2024Open, Classified
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
Z-2422-2024 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Unintended Movement; Unintended Movement
IT WAS REPORTED, ¿ON (B)(6) 2024 PATIENTS MUM CHECKED THE WATER IN BALLOON, NO WATER COULD BE EXTRACTED. ON (B)(6) 2024 PATIENTS MUM NOTED MILKY ASPIRATE FROM GASTRIC PORT AND ALSO PATIENT HAD VOMITED. THEREFORE, PATIENTS MUM REMOVED THE DEVICE AND GASTROSTOMY BUTTON." PER ADDITIONAL INFORMATION RECEIVED ON 12SEP2024, ¿THE JEJUNAL LUMEN DISPLACED INTO THE STOMACH. THEREFORE, PATIENT'S MUM REMOVED THE DEVICE AND PLACED A LOW-PROFILE MIC-KEY BUTTON IN THE TRACT AND PATIENT'S MUM MANAGED THEIR FLUIDS GASTRICALLY AT HOME AT A SLOWER RATE UNTIL THE GJ [GASTROJEJUNAL] TUBE COULD BE REPLACED IN INTERVENTIONAL RADIOLOGY.¿
Patient problems: Vomiting
MAUDE report 20397105 ↗
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.