CORFLO Controller 20-0431Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10815149022892), received between Mar 5, 2018 and Mar 5, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 4 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN TOTAL NUMBER OF PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2018-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2018-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2018-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE STYLET OF THE FEEDING TUBE BECAME DETACHED INSIDE THE PATIENT'S BODY FOR TWO DAYS. THE BREAK WAS CONFIRMED BY X-RAY. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO REMOVE THE STYLET. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7312821 ↗
• MalfunctionMar 5, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 4 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN TOTAL NUMBER OF PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2018-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2018-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2018-00005 FOR THE THIRD EVENT. IT WAS REPORTED THAT THE STYLET OF THE FEEDING TUBE BECAME DETACHED INSIDE THE PATIENT'S BODY FOR TWO DAYS. THE BREAK WAS CONFIRMED BY X-RAY. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO REMOVE THE STYLET. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7312818 ↗
• MalfunctionMar 5, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 4 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN TOTAL NUMBER OF PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2018-00004 FOR THE SECOND EVENT. REFER TO 3011270181-2018-00005 FOR THE THIRD EVENT. REFER TO 3011270181-2018-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE STYLET OF THE FEEDING TUBE BECAME DETACHED INSIDE THE PATIENT'S BODY FOR TWO DAYS. THE BREAK WAS CONFIRMED BY X-RAY. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO REMOVE THE STYLET. ADDITIONAL INFORMATION RECEIVED ON 20-FEB-2018 STATED THAT THE STYLET BECAME DAMAGED INSIDE THE PATIENT. THE PATIENT WAS NOTED TO BE OKAY AFTER THE SURGERY WAS PERFORMED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7312811 ↗
• MalfunctionMar 5, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 4 DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN TOTAL NUMBER OF PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2018-00003 FOR THE FIRST EVENT. REFER TO 3011270181-2018-00005 FOR THE THIRD EVENT. REFER TO 3011270181-2018-00006 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE STYLET OF THE FEEDING TUBE BECAME DETACHED INSIDE THE PATIENT'S BODY FOR TWO DAYS. THE BREAK WAS CONFIRMED BY X-RAY. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO REMOVE THE STYLET. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7312810 ↗