ENFit PU Feeding Tube FTM5.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770000602), received between Nov 27, 2024 and Nov 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Break

  FOUND NG [NASOGASTRIC] FEEDING TUBE BROKEN AT 38CM MARK. NO KNOWN CAUSE FOR BREAK. WAS PLACED VIA OG [ORAL GASTRIC] ROUTE AT TIME OF BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496218 ↗
• MalfunctionNov 27, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2024-00124 FOR THE SECOND EVENT. REFER TO 3011270181-2024-00125 FOR THE THIRD EVENT. IT WAS REPORTED, THERE WAS AN OCCURRENCE OF THE NASOJEJUNAL TUBE COILING IN THE PATIENT'S ESOPHAGUS. THE PATIENT REQUIRED OXYGEN BECAUSE OF THE INCIDENT.

  Patient problems: Hypoxia

  MAUDE report 20799657 ↗
• MalfunctionNov 27, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2024-00123 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00124 FOR THE SECOND EVENT. IT WAS REPORTED, THERE WAS AN OCCURRENCE OF THE NASOJEJUNAL TUBE COILING IN THE PATIENT'S ESOPHAGUS. THE PATIENT REQUIRED OXYGEN BECAUSE OF THE INCIDENT.

  Patient problems: Hypoxia

  MAUDE report 20799422 ↗
• MalfunctionNov 27, 2024Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2024-00123 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00125 FOR THE THIRD EVENT. IT WAS REPORTED, THERE WAS AN OCCURRENCE OF THE NASOJEJUNAL TUBE COILING IN THE PATIENT'S ESOPHAGUS. THE PATIENT REQUIRED OXYGEN BECAUSE OF THE INCIDENT.

  Patient problems: Hypoxia

  MAUDE report 20799327 ↗

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