PU Feeding Tube FTS5.0P-EORecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770002187), received between Nov 14, 2023 and Nov 14, 2023 — classified as 3 injuries.

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

• InjuryNov 14, 2023Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2023-00130 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00131 FOR THE SECOND REPORT. IT WAS REPORTED, NASOGASTRIC TUBE (NGT) MAL POSITIONS. THREE INSERTION ATTEMPTS WERE MADE, AND ALL WERE MAL-POSITIONED. PATIENT ORAL FEEDING WAS DELAYED BY ABOUT A WEEK. NO LONG-TERM ADVERSE PATIENT IMPACT EXPECTED. EXACT LOCATION OF MALPOSITION NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18135434 ↗
• InjuryNov 14, 2023Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2023-00131 FOR THE SECOND REPORT. REFER TO 3011270181-2023-00132 FOR THE THIRD REPORT. IT WAS REPORTED, NASOGASTRIC TUBE (NGT) MAL POSITIONS. THREE INSERTION ATTEMPTS WERE MADE, AND ALL WERE MAL-POSITIONED. PATIENT ORAL FEEDING WAS DELAYED BY ABOUT A WEEK. NO LONG-TERM ADVERSE PATIENT IMPACT EXPECTED. EXACT LOCATION OF MALPOSITION NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18135416 ↗
• InjuryNov 14, 2023Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2023-00130 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00132 FOR THE THIRD REPORT. IT WAS REPORTED, NASOGASTRIC TUBE (NGT) MAL POSITIONS. THREE INSERTION ATTEMPTS WERE MADE, AND ALL WERE MAL-POSITIONED. PATIENT ORAL FEEDING WAS DELAYED BY ABOUT A WEEK. NO LONG-TERM ADVERSE PATIENT IMPACT EXPECTED. EXACT LOCATION OF MALPOSITION NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18135404 ↗

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