CORFLO PEG Kit 50-4016E1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10815149021826), received between Oct 25, 2019 and Oct 25, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 16, 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.

• MalfunctionOct 25, 2019Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3006646024-2019-00024 FOR THE FIRST REPORT. REFER TO 3006646024-2019-00025 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE HOSPITAL HAS HAD PROBLEMS WITH THE PLACEMENT KITS WHERE THERE WAS A BLOCKAGE OR THE TIP OF THE DILATOR SEEMED TOO NARROW FOR THE GUIDEWIRE. THREE KITS FAILED CONSECUTIVELY DURING A PROCEDURE AND RESULTED IN A PERI-PROCEDURAL DELAY DUE TO LOW STOCK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238985 ↗
• MalfunctionOct 25, 2019Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3006646024-2019-00024 FOR THE FIRST REPORT. REFER TO 3006646024-2019-00026 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE HOSPITAL HAS HAD PROBLEMS WITH THE PLACEMENT KITS WHERE THERE WAS A BLOCKAGE OR THE TIP OF THE DILATOR SEEMED TOO NARROW FOR THE GUIDEWIRE. THREE KITS FAILED CONSECUTIVELY DURING A PROCEDURE AND RESULTED IN A PERI-PROCEDURAL DELAY DUE TO LOW STOCK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238980 ↗
• MalfunctionOct 25, 2019Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2019-00025 FOR THE SECOND REPORT . REFER TO 3006646024-2019-00026 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE HOSPITAL HAS HAD PROBLEMS WITH THE PLACEMENT KITS WHERE THERE WAS A BLOCKAGE OR THE TIP OF THE DILATOR SEEMED TOO NARROW FOR THE GUIDEWIRE. THREE KITS FAILED CONSECUTIVELY DURING A PROCEDURE AND RESULTED IN A PERI-PROCEDURAL DELAY DUE TO LOW STOCK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238979 ↗