ENFit PU Feeding Tube PFTL6.5P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770001807), received between May 7, 2022 and Jan 15, 2024 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2024-00008 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00009 FOR THE SECOND EVENT. IT WAS REPORTED A GASTRIC PERFORATION OCCURRED DURING USE OF THE NASOGASTRIC TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18515040 ↗
• InjuryJan 15, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2024-00008 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00010 FOR THE THIRD EVENT. IT WAS REPORTED A GASTRIC PERFORATION OCCURRED DURING USE OF THE NASOGASTRIC TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18515039 ↗
• InjuryJan 15, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO (B)(4) FOR THE SECOND EVENT. REFER TO (B)(4) FOR THE THIRD EVENT. IT WAS REPORTED A GASTRIC PERFORATION OCCURRED DURING USE OF THE NASOGASTRIC TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18515038 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2024-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2024-00005 FOR THE THIRD EVENT. REFER TO 3011270181-2024-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THERE WAS AN EVENT RELATING TO GASTRIC PERFORATION IN THE PATIENT WHO ALSO HAD AN AVANOS FEEDING TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18511070 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2024-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2024-00005 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS AN EVENT RELATING TO GASTRIC PERFORATION IN THE PATIENT WHO ALSO HAD AN AVANOS FEEDING TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18511068 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2024-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00005 FOR THE THIRD EVENT. REFER TO 3011270181-2024-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THERE WAS AN EVENT RELATING TO GASTRIC PERFORATION IN THE PATIENT WHO ALSO HAD AN AVANOS FEEDING TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18511066 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2024-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2024-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2024-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THERE WAS AN EVENT RELATING TO GASTRIC PERFORATION IN THE PATIENT WHO ALSO HAD AN AVANOS FEEDING TUBE.

  Patient problems: Bowel Perforation

  MAUDE report 18511063 ↗
• MalfunctionMay 7, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE PATIENT'S NASOGASTRIC TUBE DEVELOPED A 'PINPOINT HOLE' MIDWAY OF TUBE AFTER 2 WEEKS OF BEING IN PLACE. THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY ADDITIONAL INFORMATION RECEIVED STATED THE 'DAY CARE NOTICED WATER FROM TUBE WHEN FLUSHING.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315372 ↗

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