ENFit PU Feeding Tube FTS6.5P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770000589), received between Mar 28, 2024 and Aug 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  It was reported the feeding tube's hub was broken and it stayed in place for a "few days before home care was informed by client. Client was unable to use it on the day it was reported and the hub was broken," when discovered by staff.There was no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479770 ↗
• MalfunctionJul 29, 2026Partial Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072904 ↗
• MalfunctionMar 28, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED, "THE PATIENT IS FED THROUGH AN OG [OROGASTRIC] TUBE EVERY 2 HOURS AND EVERY 4 HOURS WE ARE TO CHANGE THE ENTERAL EXTENSION TUBING. WHEN IT WAS TIME TO FEED THE BABY FOR 0230, I WAS UNABLE TO DISCONNECT THE EXTENSION TUBING FROM THE OG TUBE. IT WAS COMPLETELY STUCK TOGETHER. I TRIED CLEANING THE CONNECTION, USED A HEATED DAMP CLOTH, A DRY FACE CLOTH AND GLOVES TO TRY TO GET THE OG AND EXTENSION TUBING APART. BUT I WAS UNSUCCESSFUL. MY POD BUDDY ATTEMPTED AS WELL AND WAS NOT SUCCESSFUL EITHER. AS A RESULT, THE OG TUBE HAD TO BE REMOVED AND A NEW ONE INSERTED ON THE PATIENT IN ORDER FOR THE BABY TO BE FED. THIS PATIENT HAS AN ISSUE WITH REGURGITATION WITH HER FEEDS AND ANY STIMULATION CAN CAUSE HER TO REFLUX OR VOMIT. AS A RESULT OF THE TUBING FAILING THIS PATIENT HAD TO BE WOKEN UP TO INSERT THE NEW OG TUBE FOR HER TO BE FED. SHE HAD A DESATURATION AND A DIP IN HER HEARTRATE DURING THIS TIME REQUIRING AN INCREASE IN OXYGEN TO HELP HER RECOVER."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Gastrointestinal Regurgitation; Low Oxygen Saturation; Vomiting

  MAUDE report 18990493 ↗

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