ENFit PU Feeding Tube FTS5.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770000572), received between Jul 29, 2026 and Sep 22, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Leak/Splash

  It was reported that while the device was in use, staff responded to patient monitors alerting to desaturation. When aspiration through the orogastric feeding tube was attempted, substantial amounts of air and little to no gastric contents were obtained. Upon reconnecting the feeding tube to the enteral extension tubing, patient feeding solution was observed leaking at the connection between the tubing and the connection hub. No patient harm was reported.

  Patient problems: Low Oxygen Saturation

  MAUDE report 50852752 ↗
• MalfunctionJul 29, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074037 ↗

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