ENFit PU Feeding Tube FTL5.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770000657), received between Dec 14, 2023 and May 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A FEEDING TUBE BROKE WHILE IN THE PATIENT. IT HAD BEEN IN PLACE FOR FOUR DAYS. WHILE CLEANING THE END WITH THE PURPLE CLEANING TOOL, THE FEEDING TUBE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161712 ↗
• MalfunctionDec 14, 2023Break; Break

  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 3011270181-2023-00139 FOR THE SECOND EVENT. IT WAS REPORTED THE TUBE BROKE WHILE INSIDE THE PATIENT. A NEW DEVICE WAS PLACED. ADDITIONAL INFORMATION RECEIVED 28-NOV-2023 STATED THE PATIENT WAS A REGIONAL NEONATAL INTENSIVE CARE UNIT (RNICU) PATIENT AND THE EVENT OCCURRED A COUPLE OF DAYS AFTER THE DEVICE WAS INSERTED. THE PATIENT IS STABLE, NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332766 ↗
• MalfunctionDec 14, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2023-00138 FOR THE FIRST EVENT. IT WAS REPORTED THE TUBE BROKE WHILE INSIDE THE PATIENT. A NEW DEVICE WAS PLACED. ADDITIONAL INFORMATION RECEIVED 28-NOV-2023 STATED THE PATIENT WAS A REGIONAL NEONATAL INTENSIVE CARE UNIT (RNICU) PATIENT AND THE EVENT OCCURRED A COUPLE OF DAYS AFTER THE DEVICE WAS INSERTED. THE PATIENT IS STABLE, NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331541 ↗

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 · Terminated
  NeoMed 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