ENFit PU Feeding Tube PFTM6.5P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770001791), received between Aug 19, 2021 and Jul 30, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085855 ↗
• MalfunctionJul 28, 2026

  It was reported that a nasogastric feeding tube clogged. A new tube was placed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054604 ↗
• MalfunctionJul 2, 2026Complete Blockage

  IT WAS REPORTED THAT A FEEDING TUBE BECAME OCCLUDED AND COULD NOT BE FLUSHED DURING USE, REQUIRING REMOVAL AND REPLACEMENT WITH A LARGER TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690277 ↗
• MalfunctionMay 11, 2026Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5176288 THE FOLLOWING: "ON (B)(6) 2025: INFANT HAD A 6.5 FRENCH OROGASTRIC TUBE NEOMED FEEDING TUBE WITH ENFIT CONNECTOR. WHEN ATTEMPTING TO AUSCULTATE IT WAS NOTED THAT AIR AND RESIDUAL FEEDING WAS COMING OUT OF TUBE AT THE 18CM MARK ON TUBE. TUBE WAS REMOVED AND NOTED TO BE SPLIT AT THE 18 CENTIMETERS MARK. TUBE WAS INSERTED ON (B)(6) 2025 AND SECURED AT 16CM. UNKNOWN HOW THE SPLIT OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143176 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THERE WAS AN EVENT IN WHICH THE "FEEDING TUBE PARTIALLY BREAK BETWEEN THE 9/10 CM MARKS. THIS BREAKAGE WAS NOTICED AFTER THE [PATIENT] PULLED OUT THE TUBE. THE [PATIENT] HAD BEEN EXPERIENCING SOME DISTRESS DURING THIS TIME."

  Patient problems: Distress

  MAUDE report 18194099 ↗
• MalfunctionAug 19, 2021Material Discolored; Material Puncture/Hole; Material Discolored; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT PULLED OUT THE ORAL GASTRIC TUBE THAT HAD BEEN PLACED ON (B)(6) 2021. AT THE DISTAL END OF THE TUBE, APPROXIMATELY 3CM BEFORE THE END, THERE WAS A "DEFECT THE SIZE OF A PINHEAD." AROUND THE AREA OF THE DEFECT WAS A 1CM AREA OF YELLOWISH DISCOLORATION. PER INFORMATION PROVIDED BY THE FACILITY, THIS EVENT WAS WITNESSED AND DESCRIBED BY THE PATIENT'S MOTHER. THE PATIENT IS DESCRIBED AS BEING MALE, (B)(6) MONTHS OLD, AND WEIGHING (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344915 ↗

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