ENFit PU Feeding Tube PFTS6.5P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770001784), received between Mar 17, 2026 and Jul 1, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Leak/Splash

  THE FAILURE ANALYSIS LABORATORY RECEIVED AN EXTRA SAMPLE. THE RETURNED SAMPLE EXHIBITED DAMAGE (TEAR/HOLE). NO ADDITIONAL INCIDENT INFORMATION, PATIENT INFORMATION, OR LOT NUMBER WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25678208 ↗
• MalfunctionJun 8, 2026Complete Blockage

  IT WAS REPORTED THAT AN NG TUBE BECAME OCCLUDED AND HARDENED ALONG A PORTION OF THE TUBE DURING USE, PREVENTING FEEDING AND REQUIRING REMOVAL AND REPLACEMENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. EVENT DATE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428014 ↗
• MalfunctionMay 20, 2026Leak/Splash

  THE CUSTOMER REPORTED THAT A NASOGASTRIC (NG) FEEDING TUBE WAS OBSERVED LEAKING ENTERAL FEEDING FORMULA FROM THE PATIENT¿S NARE DURING FEEDING ADMINISTRATION. THE PUMP FEEDING WAS STOPPED, THE NG TUBE WAS REMOVED AND REINSERTED, AND LEAKAGE WAS AGAIN OBSERVED FROM THE NARE UPON RESUMPTION OF FEEDING. A NEW NG TUBE WAS THEN INSERTED, PLACEMENT WAS VERIFIED, AND FEEDING RESUMED WITHOUT FURTHER LEAKAGE. THE REMOVED NG TUBE WAS REPORTEDLY EVALUATED AND APPEARED TO BE LEAKING FROM APPROXIMATELY THE 18¿19 CM MARKING, NEAR THE AREA WHERE THE TUBE HAD BEEN SECURED AT THE NARE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-MAY-2026, REPORTING NO INJURY AND NO HISTORY OF TUBE CLOGGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229322 ↗
• MalfunctionMar 18, 2026Obstruction of Flow; Pumping Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2026-00037 FOR THE SECOND REPORT. REFER TO 3011270181-2026-00038 FOR THE THIRD REPORT. THE CUSTOMER REPORTED THAT CLINICIANS ON THE INFANT TODDLER FLOOR EXPERIENCED OCCLUSION ALARMS WHEN USING KANGAROO PUMPS WITH AVANOS 6.5 FR NEOMED FEEDING TUBES (REF: PFTS6.5P-NC) DURING INFUSION. THE PUMP ALARMED ¿OCCLUDED¿ AND DID NOT RESPOND TO TROUBLESHOOTING. THE ISSUE OCCURRED DURING USE WITH PEDIALYTE (THIN LIQUID), AND CLINICIANS SUSPECTED A POSSIBLE PSI OR PRESSURE SETTING ISSUE RELATED TO THE FEEDING TUBE. MULTIPLE EVENTS WERE REPORTED WITH THIS TUBE SIZE OVER THE COURSE OF A WEEK. THE EXACT QUANTITY IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24630567 ↗
• MalfunctionMar 17, 2026Obstruction of Flow; Pumping Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2026-00036 FOR THE FIRST REPORT, REFER TO 3011270181-2026-00038 FOR THE THIRD REPORT. THE CUSTOMER REPORTED THAT CLINICIANS ON THE INFANT TODDLER FLOOR EXPERIENCED OCCLUSION ALARMS WHEN USING KANGAROO PUMPS WITH AVANOS 6.5 FR NEOMED FEEDING TUBES (REF: PFTS6.5P-NC) DURING INFUSION. THE PUMP ALARMED ¿OCCLUDED¿ AND DID NOT RESPOND TO TROUBLESHOOTING. THE ISSUE OCCURRED DURING USE WITH PEDIALYTE (THIN LIQUID), AND CLINICIANS SUSPECTED A POSSIBLE PSI OR PRESSURE SETTING ISSUE RELATED TO THE FEEDING TUBE. MULTIPLE EVENTS WERE REPORTED WITH THIS TUBE SIZE OVER THE COURSE OF A WEEK. THE EXACT QUANTITY IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24621348 ↗

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