ENFit PU Feeding Tube PFTL8.0P-NCRecalls & reported problems
Avanos Medical, Inc. · ENFit PU Feeding Tube Purp 8Fr 90cm · Class 2
All models of ENFit PU Feeding Tube (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770001838), received between Feb 5, 2026 and Jun 5, 2026 — classified as 2 malfunctions.
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
- Malposition of Device1
Patient problems
- Foreign Body In Patient1
- Ulcer1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Malposition of Device
AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2026-00080 FOR THE FIRST EVENT. IT WAS REPORTED THE CLINICIANS NOTED A MANDIBULAR INDENTATION ON THE INFANT THAT WAS USING THE 8FR FEEDING TUBE AS A ORAL GASTRIC DECOMPRESSION DEVICE.
Patient problems: Ulcer
MAUDE report 25414134 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THERE WAS A RECENT PATIENT EVENT IN WHICH A PATIENT IN THE CARDIAC INTENSIVE CARE UNIT (CICU) HAD TWO FRAGMENTS OF AN AVANOS NEOMED NASOGASTRIC (NG) TUBE IN THE PATIENT'S STOMACH. "FRAGMENTS WERE SEEN ON X-RAY AND REQUIRED SURGERY TO REMOVE." THERE WAS NO REPORTED INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 24274405 ↗
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-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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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