ENFit PU Feeding Tube PFTM8.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770001821), received between Apr 2, 2026 and Apr 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED VIA FDA USER FACILITY/IMPORTER REPORT NUMBER (B)(4), ¿THE PEDS NG [NASOGASTRIC] TUBES HAVE BEEN DIFFICULT OR NEAR IMPOSSIBLE TO CAP. ONCE THE TUBE HAS BEEN PLACED AND TAPED ON THE PATIENT, THE DISTAL END WITH THE SMALL PURPLE CAP DOES NOT FIT WELL INTO THE HOLE TO SEAL IT OFF. THIS HAS LED TO LOSS OF MEDS, FEEDS, ETC. THAT HAVE DRIPPED OUT OF THE LINE. IT APPEARS THAT THE DISTAL CAP BECOMES DEFORMED AFTER EACH USE (UNCAP AND RECAP).¿ THE EVENT OCCURRED IN FEBRUARY 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769412 ↗

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