ENFit PU Feeding TubeRecalls & reported problems across all models
Avanos Medical, Inc. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 1
- Injuries reported
- 9
- Recalls
- 0
We found 15 models of ENFit PU Feeding Tube by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Aug 19, 2021 and Sep 22, 2026 — classified as 1 death, 9 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Break” (12 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ENFit PU Feeding Tube problems
Device problems
- Break12
- Leak/Splash10
- Malposition of Device9
- Adverse Event Without Identified Device or Use Problem7
- Complete Blockage6
- Material Puncture/Hole6
- Obstruction of Flow2
- Pumping Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information9
- Bowel Perforation8
- Hypoxia3
- Low Oxygen Saturation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Bradycardia1
ENFit PU Feeding Tube models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENFit PU Feeding Tube PFTM5.0P-NCTUBE, NASOGASTRIC10 reports
- ENFit PU Feeding Tube PFTL6.5P-NCTUBE, NASOGASTRIC8 reports
- ENFit PU Feeding Tube FTM6.5P-NCTUBE, NASOGASTRIC6 reports
- ENFit PU Feeding Tube PFTM6.5P-NCTUBE, NASOGASTRIC6 reports
- ENFit PU Feeding Tube PFTS6.5P-NCTUBE, NASOGASTRIC5 reports
- ENFit PU Feeding Tube FTM5.0P-NCTUBE, NASOGASTRIC4 reports
- ENFit PU Feeding Tube PFTS5.0P-NCTUBE, NASOGASTRIC4 reports
- ENFit PU Feeding Tube FTS6.5P-NCTUBE, NASOGASTRIC3 reports
- ENFit PU Feeding Tube FTL5.0P-NCTUBE, NASOGASTRIC3 reports
- ENFit PU Feeding Tube FTS5.0P-NCTUBE, NASOGASTRIC2 reports
- ENFit PU Feeding Tube PFTL8.0P-NCTubes, gastrointestinal (and accessories)2 reports
- ENFit PU Feeding Tube FTM8.0P-NCTUBE, NASOGASTRIC1 death1 report
- ENFit PU Feeding Tube FTL6.5P-NCTUBE, NASOGASTRIC1 report
- ENFit PU Feeding Tube PFTS8.0P-NCTUBE, NASOGASTRIC1 report
- ENFit PU Feeding Tube PFTM8.0P-NCTUBE, NASOGASTRIC1 report
Recent ENFit PU Feeding Tube adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Leak/Splash
It was reported that while the device was in use, staff responded to patient monitors alerting to desaturation. When aspiration through the orogastric feeding tube was attempted, substantial amounts of air and little to no gastric contents were obtained. Upon reconnecting the feeding tube to the enteral extension tubing, patient feeding solution was observed leaking at the connection between the tubing and the connection hub. No patient harm was reported.
Patient problems: Low Oxygen Saturation
MAUDE report 50852752 ↗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 ↗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 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085855 ↗MalfunctionJul 29, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074037 ↗MalfunctionJul 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50074031 ↗MalfunctionJul 29, 2026Partial Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50072904 ↗MalfunctionJul 28, 2026
It was reported that a nasogastric feeding tube clogged. A new tube was placed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054604 ↗MalfunctionJul 28, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054372 ↗MalfunctionJul 28, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054354 ↗MalfunctionJul 28, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054353 ↗MalfunctionJul 28, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054351 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054347 ↗MalfunctionJul 28, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054344 ↗MalfunctionJul 2, 2026Complete Blockage
IT WAS REPORTED THAT A FEEDING TUBE BECAME OCCLUDED AND COULD NOT BE FLUSHED DURING USE, REQUIRING REMOVAL AND REPLACEMENT WITH A LARGER TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25690277 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- Ballard* Closed Suction System for Adults17 models · 121 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- Cortrak 2 Enternal access device14 models · 164 reports
- NEOMED*24 models · 0 reports · 3 recalls
- Microcuff* Endotracheal Tube for Adults8 models · 102 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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