AVANOS 95484Recalls & reported problems
Avanos Medical, Inc. · MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770954844), received between Feb 20, 2020 and Feb 4, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1187-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Complete Blockage1
Patient problems
- Unspecified Infection1
- Vomiting1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S FAMILY MEMBER DESCRIBED THE TUBING AS HAVING A CLEAR, ROUND, PLASTIC PLATE THAT WAS HELD IN PLACE WITH A BALLOON. THE FAMILY MEMBER STATED THE PATIENT BEGAN TO EXPERIENCE INCREASED DRAINAGE AND PAIN AROUND (B)(6) 2020. THE PATIENT WAS RECEIVING LEVODOPA/CARBIDOPA. ON (B)(6) 2020 THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR THE EVENTS AND WAS DIAGNOSED WITH A STOMA SITE INFECTION. THE PATIENT WAS TREATED WITH ORAL BACTRIM. THE EVENT OF STOMA INFECTION HAS RESOLVED. THE PEG TUBE WAS LAST REPLACED ON (B)(6) 2020. THE FAMILY REPORTED THE PATIENT TOOK HIS LAST DOSE OF ANTIBIOTICS AND HE WOULD UNDERGO TUBING REPLACEMENT VIA INTERVENTIONAL RADIOLOGY.
Patient problems: Unspecified Infection
MAUDE report 11282717 ↗MalfunctionFeb 20, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED THE ENTERAL FEEDING DEVICE DID NOT LAST AS LONG AS ANTICIPATED. THE TRIPLE LUMEN GASTRIC-JEJUNAL DEVICE SHIFTED AND CAUSED A BLOCKAGE WHICH NECESSITATED THE PATIENT BEING HOSPITALIZED. THE PATIENT EXPERIENCED CYCLIC VOMITING SYNDROME WHEN THE ENTERAL FEEDING TUBE MALFUNCTIONED. ADDITIONAL INFORMATION RECEIVED 28-JAN-2020 STATED THE DEVICE WAS REPLACED AT THE HEALTH CENTRE IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT.
Patient problems: Vomiting
MAUDE report 9732337 ↗
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 · each recall links to the FDA recall notice
- 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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