InTRAkit™ INT6F11A3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169712270), received between Apr 6, 2017 and Apr 7, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionApr 7, 2017Break; Break

  THE PHYSICIAN INTENDED TO USE A 6F INTRAKIT INTRODUCER. NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. NO ISSUES WERE NOTED WHEN INSPECTED ON REMOVAL FROM PACKAGING. THE DEVICE WAS PREPPED PER IFU. THE DEVICE WAS PROPERLY HYDRATED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. EXCESSIVE FORCE WAS NOT APPLIED. IT IS REPORTED THAT AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DILATOR FROM THE SHEATH THE HUB WAS SEPARATED FROM THE DILATOR. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6471161 ↗
• MalfunctionApr 6, 2017Break; Break

  THE PHYSICIAN INTENDED TO USE A 6F INTRAKIT INTRODUCER. NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. NO ISSUES WERE NOTED WHEN INSPECTED ON REMOVAL FROM PACKAGING. THE DEVICE WAS PREPPED PER IFU. THE DEVICE WAS PROPERLY HYDRATED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. EXCESSIVE FORCE WAS NOT APPLIED. IT IS REPORTED THAT AS THE PHYSICIAN ATTEMPTED TO REMOVE THE DILATOR FROM THE SHEATH THE HUB SEPARATED FROM THE DILATOR. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463860 ↗