CORFLO ULTRA Lite NG Feeding Tube 20-9366AIV2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10815149023851), received between Jun 6, 2017 and Aug 31, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2018-00141 FOR THE FIRST EVENT. IT WAS REPORTED THE NASOGASTRIC (NG) TUBE HAD PINPOINT HOLES AND WAS LEAKING. THERE WAS NO REPORTED PATIENT HARM, BUT THE CLINICIANS HAD TO REINSERT A NEW NG TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838417 ↗
• MalfunctionAug 31, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2018-00142 FOR THE SECOND EVENT. IT WAS REPORTED THE NASOGASTRIC (NG) TUBE HAD CRACKS ON THE TUBE AFTER INSERTION. THERE WAS NO REPORTED PATIENT HARM, BUT THE CLINICIANS HAD TO REINSERT A NEW NG TUBE. ADDITIONAL INFORMATION RECEIVED 09-AUG-2018 STATED THERE WERE TWO SMALL CRACKS IN THE TUBE CAUSING WATER AND AIR TO LEAK IN TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838394 ↗
• MalfunctionJun 6, 2017Material Fragmentation; Material Fragmentation

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3009124963-2017-00023 FOR THE FIRST EVENT. A REPORT WAS RECEIVED STATING THE TUBE IS FLAKING. THE FLAKING FRAGMENTS WERE NOTED IN THE PATIENT'S FECES. THE PARENT REPORTS USING VASELINE AT THE TIPOFF THE DEVICE FOR INSERTION OF THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616089 ↗
• MalfunctionJun 6, 2017Material Fragmentation; Material Fragmentation

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3009124963-2017-00024 FOR THE SECOND EVENT. A REPORT WAS RECEIVED STATING THE TUBE IS FLAKING. THE FLAKING FRAGMENTS WERE NOTED IN THE PATIENT'S FECES. THE PARENT REPORTS USING VASELINE AT THE TIP OF THE DEVICE FOR INSERTION OF THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616086 ↗