CORFLO ULTRA NG Feeding Tube 20-7431AIV2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10815149023516), received between Jun 29, 2018 and Aug 9, 2018 — classified as 3 malfunctions.

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

• MalfunctionAug 9, 2018Deformation Due to Compressive Stress

  CORPAK CORFLO ENTERAL FEEDING TUBE GUIDEWIRE AND TUBING KINKED, UNABLE TO FLUSH OR USE. REF 20-7431AIV2, LOT 79540, (B)(4). TUBE REMOVED AND REPLACED WITH EFFECTIVE DEVICE. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7769700 ↗
• MalfunctionJun 29, 2018Hole In Material; Hole In Material

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2018-00021 FOR THE FIRST EVENT. IT WAS REPORTED THAT A DOBHOFF FEEDING TUBE WAS INSERTED, AND PLACEMENT WAS CONFIRMED. WHEN THE NURSE STARTED TO USE THE FEEDING TUBE, THE MEDICATION EXPELLED OUT OF A SLIT/HOLE IN THE TUBING. THE FEEDING TUBE WAS REMOVED AND SAVED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SLIT WAS LOCATED IN THE NASAL AREA. THE CENTIMETERS WERE NOT MARKED, BUT IT WAS NOTED THAT THE NASAL AREA IS USUALLY AROUND 65 CM. FDA USER FACILITY REPORT # 3600840000-2018-8015 WAS RECEIVED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652840 ↗
• MalfunctionJun 29, 2018Hole In Material; Hole In Material

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2018-00022 FOR THE SECOND EVENT. IT WAS REPORTED THAT A DOBHOFF FEEDING TUBE WAS INSERTED, AND PLACEMENT WAS CONFIRMED. WHEN THE NURSE STARTED TO USE THE FEEDING TUBE, THE MEDICATION EXPELLED OUT OF A SLIT/HOLE IN THE TUBING. THE FEEDING TUBE WAS REMOVED AND SAVED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SLIT WAS LOCATED IN THE NASAL AREA. THE CENTIMETERS WERE NOT MARKED, BUT IT WAS NOTED THAT THE NASAL AREA IS USUALLY AROUND 65 CM. FDA USER FACILITY REPORT # 3600840000-2018-8015 WAS RECEIVED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652832 ↗