ENFit SIL Feeding Tube PFTL8.0S-NCRecalls & reported problems
Avanos Medical, Inc. · ENFit SIL Feeding Tube Purp 8Fr 90cm · Class 2
Data updated Oct 18, 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 00350770000879), received between Jan 6, 2026 and Jan 6, 2026 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2026Break
IT WAS REPORTED, NASOGASTRIC TUBE BROKE WHILE IN USE ON THE PATIENT. PATIENT HAD EVENTS OF DESATURATIONS RELATED TO THE TEAR. X-RAY PERFORMED AND NO PORTION OF TUBING WAS RETAINED INSIDE OF THE PATIENT. PATIENT IT CURRENTLY STABLE. DENIES ANY ISSUE WITH THE TUBE CLOGGING PRIOR TO BREAK.
Patient problems: Low Oxygen Saturation
MAUDE report 23978316 ↗
Other TUBE, FEEDING devices
- Bard® Premature Infant Feeding Tube 0036400C. R. Bard, Inc. · TUBE, FEEDING5 reports
- CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9431TRAK2ACorpak Medsystems, Inc. · TUBE, FEEDING5 reports
- EndoVive Jejunal Feeding Tube M00566350Boston Scientific Corporation · TUBE, FEEDING4 reports
- CORFLO ULTRA Lite NG Feeding Tube 20-9366AIV2Corpak Medsystems, Inc. · TUBE, FEEDING4 reports
- AVANOS 20-9366AIV2Avanos Medical, Inc. · TUBE, FEEDING4 reports
- CORFLO ULTRA NG Feeding Tube 20-7431AIV2Corpak Medsystems, Inc. · TUBE, FEEDING3 reports
- CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9551TRAK2ACorpak Medsystems, Inc. · TUBE, FEEDING2 reports
- Halyard 45758Avanos Medical, Inc. · TUBE, FEEDING2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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