AVANOS 46211Recalls & reported problems
Avanos Medical, Inc. · CORFLO* Standard PEG Kit - Pull Method · 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 00350770462110), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Break; Break
IT WAS REPORTED THE PEG TUBE JUST FELL OUT WITH NO INTERNAL FIXATION ON THE END. INTERNAL BUMPER COMPLETELY DISCONNECTED FROM TUBE. PEG INSERTED (B)(6) 2025, CAME OUT (B)(6) 2025. THE PATIENT VOMITED UP THE BUMPER ALMOST 2-DAYS LATER. ADDITIONAL INFORMATION RECEIVED (B)(6) 2025 STATED AT THE TIME OF TUBE REMOVAL THE PATIENT WAS AT HOME. THE PATIENT HAS HOWEVER BEEN AN INPATIENT HERE SINCE THE (B)(6), NOT FEEDING TUBE RELATED, "ONGOING INFECTION AND DERANGED BLOODS." THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WAS JUST FOR VENTING HE HAS A FEEDING GASTROSTOMY.
Patient problems: Foreign Body In Patient; Vomiting
MAUDE report 23625004 ↗
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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