PU Feeding Tube FTM5.0P-EORecalls & reported problems
Avanos Medical, Inc. · PU Feeding Tube Orange 5Fr 60cm · 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 00350770002217), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 injury.
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
Patient problems
- Perforation of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024
THE AVANOS POLYURETHANE NEONATAL FEEDING TUBES WERE SUSPECTED TO BE ASSOCIATED WITH THREE NEONATAL ESOPHAGEAL PERFORATIONS DURING INSERTION. OROGASTRIC TUBE PLACEMENT ATTEMPTED WITH RESISTANCE MET. ATTEMPTED TO PLACE WITH SMALLER OROGASTRIC TUBE WITH RESISTANCE AGAIN MET.
Patient problems: Perforation of Esophagus
MAUDE report 20722752 ↗
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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