PU Feeding Tube PFTM6.5P-EORecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770002347), received between Feb 5, 2026 and Jul 28, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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 28, 2026Complete Blockage; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060536 ↗
• MalfunctionFeb 5, 2026Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2026-00015 FOR THE FIRST REPORT. REFER TO 3011270181-2026-00017 FOR THE THIRD REPORT. REFER TO 3011270181-2026-00018 FOR THE FOURTH REPORT. IT WAS REPORTED, THE TUBE WAS BEING CHECKED FOR PROPER PLACEMENT AND WAS FOUND TO BE BLOCKED. ASPIRATION, INSUFFLATION OF AIR, AND FLUSHING WITH STERILE WATER WERE UNSUCCESSFUL. AFTER THE ORIGINAL OROGASTRIC (OG) TUBE WAS REMOVED, AN ATTEMPT WAS MADE TO FLUSH WATER THROUGH IT, BUT FLUSHING WAS STILL NOT POSSIBLE.

  Patient problems: Insufficient Information

  MAUDE report 24273121 ↗
• MalfunctionFeb 5, 2026Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2026-00016 FOR THE SECOND REPORT REFER TO 3011270181-2026-00017 FOR THE THIRD REPORT. REFER TO 3011270181-2026-00018 FOR THE FOURTH REPORT. IT WAS REPORTED, NASOGASTRIC TUBE BLOCKED.

  Patient problems: Insufficient Information

  MAUDE report 24273064 ↗
• MalfunctionFeb 5, 2026Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2026-00015 FOR THE FIRST REPORT REFER TO 3011270181-2026-00016 FOR THE SECOND REPORT . REFER TO 3011270181-2026-00017 FOR THE THIRD REPORT. IT WAS REPORTED, FEEDING TUBE IS BLOCKED.

  Patient problems: Insufficient Information

  MAUDE report 24273030 ↗
• MalfunctionFeb 5, 2026Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2026-00015 FOR THE FIRST REPORT REFER TO 3011270181-2026-00016 FOR THE SECOND REPORT REFER TO 3011270181-2026-00018 FOR THE FOURTH REPORT IT WAS REPORTED, "OROGASTRIC TUBE IN SITU AND BECAME CLOGGED. FEEDING TUBE BECAME CLOGGED AND WAS NO LONGER FUNCTIONING. NOT ABLE TO ASPIRATE OR FLUSH THE FEEDING TUBE. THE FEEDING PUMP WAS ALSO RINGING OFF THAT THE FEEDING TUBE WAS OCCLUDED."

  Patient problems: Insufficient Information

  MAUDE report 24273011 ↗

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