InTRAkit™ INT6F11C2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169712263), received between Dec 6, 2017 and Dec 11, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• InjuryDec 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A 6F INTRAKIT DEVICE. THERE WAS NO DAMAGE TO THE 6F INTRAKIT PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED AND HYDRATED PER IFU WITH NO ISSUES. DURING INSERTION INTO THE PATIENT'S RADIAL ARTERY, THE HUB OF THE DILATOR BROKE. THE DILATOR WAS STUCK INSIDE THE SHEATH. THE SHEATH AND PART OF THE DILATOR THAT REMAINED INSIDE THE SHEATH WAS COMPLETELY REMOVED WITHOUT THE USE OF ANY ADDITIONAL EQUIPMENT. NO RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH DURING PREP. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO FORCE WAS USED. THE DEVICE WAS NOT BENT EXCESSIVELY PRIOR TO THE DETACHMENT. THE PHYSICIAN SWITCHED THE HAND OF THE PATIENT FOR PCI. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104225 ↗
• InjuryDec 6, 2017Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT DEVICE DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING OF THE 6F INTRAKIT. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS PROPERLY HYDRATED. NO RESISTANCE WAS ENCOUNTERED DURING INSERTION AND NO FORCE WAS APPLIED. LEAKAGE OF THE SHEATH THROUGH THE HUB OCCURRED DURING INSERTION, WITH A LOT OF BLOOD LOSS. THERE WAS NO ISSUE WITH THE DILATOR. NO SPECIAL INTERVENTION WAS REQUIRED. THE PHYSICIAN REPLACED THE SHEATH WITH A NON-MEDTRONIC SHEATH. THE PATIENT IS ALIVE WITH NO INJURY REPORTED. THE AGE OF THE PATIENT IS APPROXIMATE.

  Patient problems: Blood Loss

  MAUDE report 7086049 ↗