ENFit PU Feeding Tube PFTS5.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770001753), received between May 17, 2024 and Sep 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 17, 2026Break

  It was reported the patient's mucous fistula was being "refed taking ostomy content and refeeding through mucous fistula with a gastric tube at 9cm. The gastric tube "[was]" tied with a suture, and the suture strings are placed under the Hollister appliance, and the tube "[was]" also secured by Duoderm and ETT "[endotracheal tube]" tape." The clinician changed mucous fistula appliance at 0750-hours due to leakage and was secure after changed. At 1020-hours the patient was crying and the clinician noted ostomy output on the blanket outside mucous fistula. The clinician noted that the gastric tube was "broken" off from the gastric tube hub. The gastric tube was noted to be stretched out and broken down due continuous acidic stool content moving through the tube. This resulted in the ostomy output draining into the bed and not the gastric tube. It is unknown when the gastric tube broke off. The Hollister pouch remained intact. The Charge clinician and team were notified, and the gastric tube was removed and area cleansed and dressed. The healthcare provider came to reinsert the gastric tube at 1210-hours, there were no complications and refeeding was resumed."

  Patient problems: Insufficient Information

  MAUDE report 50806201 ↗
• MalfunctionJun 9, 2026Break; Migration or Expulsion of Device

  THE CUSTOMER REPORTED THAT A NASOGASTRIC FEEDING TUBE BROKE DURING USE. THE PATIENT REPORTEDLY BEGAN VOMITING, DEVELOPED BRADYCARDIA AND OXYGEN DESATURATION, AND THE FEEDING TUBE WAS OBSERVED PROTRUDING FROM THE MOUTH. THE SECUREMENT DEVICE REMAINED IN PLACE AND THE BROKEN PORTION OF THE TUBE WAS REMOVED. ADDITIONAL INFORMATION REPORTED THAT THE TUBE PHYSICALLY SNAPPED AT APPROXIMATELY THE 26-CENTIMETER MARKING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON MAY 26, 2026, REPORTED THAT THE TUBE PHYSICALLY SNAPPED AT THE PROXIMAL END WHERE THE SYRINGE CONNECTS.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 25443305 ↗
• MalfunctionMay 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A NASOGASTRIC (NG) FEEDING TUBE WAS SUSPECTED TO HAVE A HOLE AFTER MULTIPLE PLACEMENT ATTEMPTS FAILED TO CONFIRM POSITION VIA AUSCULTATION. A SECOND FEEDING TUBE WAS PLACED AT THE SAME DEPTH AND PLACEMENT WAS SUCCESSFULLY CONFIRMED, INDICATING A LIKELY DEFECT IN THE INITIAL DEVICE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104769 ↗
• MalfunctionMay 17, 2024Break; Break

  IT WAS REPORTED, ¿WHEN CHANGING THE BABY¿S DIAPER 1.5 CM OF A TUBE WAS FOUND IN THE STOOL. ON INSPECTION IT LOOKED LIKE THE TIP OF A GASTRIC TUBE. I SHOWED THE FATHER AND CALLED DR TO THE BEDSIDE. WE REMOVED THE NEOMED ENFIT 5 FR NASOGASTRIC (NG) TUBE AND THE TIP WAS MISSING. THE PIECE IN THE DIAPER WAS THE TIP OF THE NG TUBE. A NEW NEOMED ENFIT 5 FR NG TUBE WAS PLACED. ON REVIEW, IT WAS FOUND THAT THE NG TUBE IN QUESTION WAS PLACED ON (B)(6) 2024. THE MANUFACTURE RECOMMENDATION IS THE TUBE SHOULD BE CHANGED OUT ON OR BEFORE 30 DAYS.¿ THE TUBE WAS REMOVED AND REPLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19343541 ↗

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