AVANOS 44547Recalls & reported problems
Avanos Medical, Inc. · MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Endoscopic/Radiologic Placement · 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770445472), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 injury.
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.
Recalls naming this device
- Jan 16, 2024Open, Classified
MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.
Z-1186-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Local Reaction1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT EXPERIENCED AN ALLERGIC "ALMOST IMMEDIATELY" AFTER PLACEMENT OF AN 18FR ENFIT MIC GASTROSTOMY-JEJUNOTOMY (GJ) TUBE ON (B)(6) 2021. THE PATIENT DEVELOPED A RASH ON HIS LEGS THAT PROGRESSED TO THE ABDOMEN AND CHEST. THE PATIENT DID NOT EXPERIENCE DIFFICULTY WITH BREATHING AND/OR SWELLING. THE PATIENT IS RECEIVING SYSTEMIC PREDNISONE AND TOPICAL BETAMETHASONE OINTMENT TO RASH AREAS. THE PATIENT ALSO RECEIVED OMNIPAQUE DYE THROUGH THE TUBE AT THE TIME OF PLACEMENT. PATIENT HAS RECEIVED FEEDINGS VIA MIC TUBES FOR 10-15 YEARS WITHOUT ANY REACTION. THE DEVICE REMAINS IN USE.
Patient problems: Local Reaction; Rash
MAUDE report 12530132 ↗
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.