AVANOS 44156Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors · Class 2 · Implant
- 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 00350770441566), received between Apr 3, 2024 and Apr 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Feeding Problem1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED, "PATIENT ADMITTED (B)(6) 2024 FOR HYDRATION DUE TO JEJUNOSTOMY-TUBE MALFUNCTIONING AND UNABLE TO TUBE FEED. THE TUBE WAS RECENTLY EXCHANGED ON (B)(6) 2024. PATIENT BROUGHT TO INTERVENTIONAL RADIOLOGY TO EXCHANGE OUT MALFUNCTIONING TUBE ON (B)(6) 2024. REMOVAL WAS VERY PAINFUL AND MIC-KEY JEJUNOSTOMY TUBE WAS FOUND TO BE ALMOST COMPLETELY TORN JUST DISTAL TO THE BALLOON." PER ADDITIONAL INFORMATION RECEIVED ON 14-MAR-2024, ¿THE EXCHANGE WHERE THE 8230-14-4.0 TUBE WAS PLACED (B)(6) 2024 WENT WELL AND THE POST PLACEMENT CONTRAST PICTURES DIDN'T SHOW SIGNS OF DAMAGE. THE PATIENT SHOWED UP TO THE EMERGENCY DEPARTMENT ON (B)(6) 2024 RELATED TO THE TUBE MALFUNCTION AND PAIN AT THE TRACT WHILE FLUSHING THROUGH THE TUBE WHICH ULTIMATELY LED TO IT BEING EXCHANGED (B)(6) 2024 WHEN INTERVENTIONAL RADIOLOGY (IR) SERVICE WAS AVAILABLE FOR A STANDARD MIC 14FR J-TUBE TO ALLOW FOR TRACT HEALING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY AND THERE WERE NO PROBLEMED NOTED WITH NEW TUBE.¿
Patient problems: Feeding Problem; Pain
MAUDE report 19035520 ↗
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.