PU Feeding Tube FTS6.5P-EORecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770002194), received between Aug 28, 2023 and Sep 19, 2023 — classified as 2 malfunctions.

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

• MalfunctionSep 19, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, ¿INFANT WAS CONTINUING TO HAVE BRADYCARDIA AND WAS INTOLERANT OF FEEDS WHENEVER ANYTHING WAS INTRODUCED TO THE FEEDING TUBE. A LOT OF AIR WAS BEING ASPIRATED AT A TIME. STAFF HAD TROUBLESHOT EVERY OTHER POTENTIAL CAUSE OF BRADYCARDIA AND X-RAY WAS PERFORMED. SUSPECTED A HOLE PRESENT IN GASTRIC TUBE. TUBE SWABBED AND FOUND A HOLE ON THE TUBE. NEW TUBE WAS PLACED, AND BABE [INFANT] GREATLY IMPROVED.¿ PER ADDITIONAL INFORMATION RECEIVED ON 4AUG2023, THE TUBE WAS IN PLACE FOR LESS THAN 12 HOURS. THE HOLE WAS NOTED AT THE 11 CM MARK. THE X-RAY RESULTS SHOWED ¿TUBE IN GOOD POSITION HOWEVER VERY SMALL GASTRIC BUBBLE NOTED (DID NOT ALIGN WITH AMOUNT OF AIR BEING ASPIRATED).¿ THE TUBE WAS NOT CLOGGED PRIOR TO THIS INCIDENT OCCURRING.

  Patient problems: Bradycardia

  MAUDE report 17772542 ↗
• MalfunctionAug 28, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, ¿INFANT WAS CONTINUING TO HAVE BRADYCARDIA AND WAS INTOLERANT OF FEEDS WHENEVER ANYTHING WAS INTRODUCED TO THE FEEDING TUBE. A LOT OF AIR WAS BEING ASPIRATED AT A TIME. STAFF HAD TROUBLESHOT EVERY OTHER POTENTIAL CAUSE OF BRADYCARDIA AND X-RAY WAS PERFORMED. SUSPECTED A HOLE PRESENT IN GASTRIC TUBE. TUBE SWABBED AND FOUND A HOLE ON THE TUBE. NEW TUBE WAS PLACED, AND BABE [INFANT] GREATLY IMPROVED.¿ PER ADDITIONAL INFORMATION RECEIVED ON 4AUG2023, THE TUBE WAS IN PLACE FOR LESS THAN 12 HOURS. THE HOLE WAS NOTED AT THE 11 CM MARK. THE X-RAY RESULTS SHOWED ¿TUBE IN GOOD POSITION HOWEVER VERY SMALL GASTRIC BUBBLE NOTED (DID NOT ALIGN WITH AMOUNT OF AIR BEING ASPIRATED).¿ THE TUBE WAS NOT CLOGGED PRIOR TO THIS INCIDENT OCCURRING.

  Patient problems: Bradycardia

  MAUDE report 17636022 ↗

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