ENFit PU Feeding Tube FTM8.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770000626), received between Jun 1, 2023 and Jun 1, 2023 — classified as 1 death.

The most frequently reported specific device problem is “Malposition of Device” (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.

• DeathJun 1, 2023Malposition of Device; Malposition of Device

  FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) REPORTED, ¿OG (OROGASTRIC (OG) TUBE) CAUSED POSTERIOR PHARYNX PERFORATION LEADING TO PNEUMOMEDIASTINUM. PATIENT BORN VIA C-SECTION. ADMITTED TO [NEONATAL INTENSIVE CARE UNIT] NICU AND OG WAS INSERTED BY [REGISTERED NURSE] RN. MET RESISTANCE AND UNABLE TO ADVANCE. SMALLER OG WAS INSERTED TO 10 CM BY ANOTHER RN BUT UNABLE TO BE ADVANCED FURTHER. ON CHEST X-RAY, MEDIASTINAL AIR AND AIR TRACKING UP TO NECK SEEN. [EAR NOSE AND THROAT] ENT PERFORMED EVALUATION WITH CAMERA, DEMONSTRATING OG PERFORATED THROUGH POSTERIOR PHARYNX. OG WAS REMOVED.¿ FDA USER FACILITY REPORT MW REPORT (B)(4) ADDITIONALLY REPORTED, ¿PER NOTE FROM MEDICAL DIRECTOR: THIS WAS A PATIENT WITH HIGH RISK FOR CARDIOPULMONARY DEMISE BASED ON PERINATAL CIRCUMSTANCES OF EARLY AND PROLONGED PRETERM RUPTURE OF MEMBRANES. ALTHOUGH THE ESOPHAGEAL PERFORATION DID RESULT IN PNEUMOMEDIASTINUM, THE CHEST X-RAYS DEMONSTRATED NO APPRECIABLE LUNG EXPANSION DESPITE MAXIMAL VENTILATOR SUPPORT. THIS INFANT'S CARE WAS REDIRECTED AS A RESULT OF THE LATTER, AND I DO NOT BELIEVE THE OG PERFORATION CONTRIBUTED SIGNIFICANTLY TO THE DEATH.¿

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17043484 ↗

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