PU Feeding Tube FTS4.0P-EORecalls & reported problems
Avanos Medical, Inc. · PU Feeding Tube Orange 4Fr 40cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770002170), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
1 other recall cover devices cleared under the same FDA submission (K082238); they may or may not involve this specific model.
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
- Malposition of Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED, NASOGASTRIC TUBE INSERTED, FOUND TO BE MALPOSITIONED ON X-RAY. TUBE REMOVED. A NEW TUBE INSERTED AS A CRITICAL TUBE WITHOUT FURTHER ISSUE. NO INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 18134855 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082238. One submission often covers many models, so check the product and lot details in each record.
- Z-0093-2019 · Jun 4, 2018 · TerminatedNeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tu
Other TUBE, NASOGASTRIC devices
- Bard® Nasogastric Sump Tube with Enfit™ EN0042140C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall4 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042120C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042160C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042180C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall2 reports
- Bard® Nasogastric Sump Tube with Enfit™ EN0042100C. R. Bard, Inc. · TUBE, NASOGASTRIC1 recall0 reports
- Bard® Nasogastric Sump Tube 0042160C. R. Bard, Inc. · TUBE, NASOGASTRIC13 reports
- ENFit PU Feeding Tube PFTM5.0P-NCAvanos Medical, Inc. · TUBE, NASOGASTRIC10 reports
- ENFit PU Feeding Tube PFTL6.5P-NCAvanos Medical, Inc. · TUBE, NASOGASTRIC8 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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