ENFit PU Feeding Tube FTM6.5P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770000619), received between Jan 30, 2023 and Jul 2, 2026 — classified as 6 malfunctions.

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

• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT A NASOGASTRIC TUBE BROKE IN TWO WHEN THEY WERE PREPARING IT FOR FEEDING AND SOME TENSION WAS PLACED ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25690271 ↗
• MalfunctionJan 26, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2026-00010 FOR THE SECOND REPORT , REFER TO 3011270181-2026-00007 FOR THE THIRD REPORT. IT WAS REPORTED, NASOGASTRIC TUBE LEAKS BELOW ENFIT CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 24176546 ↗
• MalfunctionJan 26, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2026-00009 FOR THE FIRST REPORT. REFER TO 3011270181-2026-00007 FOR THE THIRD REPORT. IT WAS REPORTED, NASOGASTRIC TUBE LEAKS BELOW ENFIT CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 24176545 ↗
• MalfunctionJan 22, 2026Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2026-00005 FOR THE FIRST REPORT, REFER TO 3011270181-2026-00006 FOR THE SECOND REPORT. IT WAS REPORTED, NASOGASTRIC TUBE LEAKS BELOW ENFIT CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 24148759 ↗
• MalfunctionJan 31, 2023Incomplete or Missing Packaging

  PATIENT WAS TO HAVE AN NG PLACED AND THE NURSE OBTAINED THE NEOMED FEEDING TUBE WITH ENFIT CONNECTOR. BEFORE OPENING THE PACKAGE, THE NURSE NOTED IT DID NOT CONTAIN THE CAP PIECE TO THE CATHETER WHICH MADE IT SO THAT THE CATHETER COULD NOT BE CLAMPED OFF. THE TUBE WAS NOT USEABLE. HAS BEEN REPORTED THAT THIS IS NOT THE FIRST TUBE THAT DID NOT HAVE A CAP.

  Patient problems: Insufficient Information

  MAUDE report 16271592 ↗
• MalfunctionJan 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE TUBE (WHICH WAS IN A PATIENT) WAS FOUND IN 2-PIECES. IT APPEARED TO HAVE BEEN CUT AT ABOUT THE 19CM MARK, BUT NO ONE REPORTS HAVING HAD SCISSORS ANYWHERE NEAR THE BED OR ANYTHING SUSPICIOUS THAT WOULD EXPLAIN IT. IT JUST FELL APART. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 04-JAN-2023 STATED, THE TUBE WAS FOUND IN THE BED, AND WAS DISCOVERED DURING REMOVAL WHEN THE REGISTERED NURSE (RN) WAS CHANGING THE TUBE. THE TUBE AS PLACED ON (B)(6) 2022 AND WAS USED FOR LIQUIDS ONLY, IT HAD BEEN IN PLACE 8.5 DAYS. THERE WAS NO ADVERSE EVENT RELATED TO THE INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 16265342 ↗

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