InTRAkit™ INT6F11C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169712232), received between Jul 21, 2017 and Dec 18, 2017 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WERE NO ISSUES NOTED WITH THE INTRAKIT PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED AND PROPERLY HYDRATED PER IFU. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING INSERTION. THE DILATOR HUB DETACHED WHILE IN THE PATIENT¿S PROXIMAL RIGHT RADIAL ARTERY. THE REMAINING PART WAS PULLED OUT. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126198 ↗
• MalfunctionDec 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A INTRAKIT 6F DEVICE. NO DAMAGE WAS NOTED TO THE INTRAKIT 6F PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE DEVICE WAS PROPERLY HYDRATED. THE DEVICE WAS PLACED IN THE RADIAL ARTERY. NO RESISTANCE WAS NOTED DURING INSERTION, AND NO FORCE WAS APPLIED. ATTENTION WAS GIVEN WHEN INSERTING THE DILATOR IN THE SHEATH. AFTER INSERTION OF THE DEVICE IN THE PATIENT, WHEN REMOVING THE DILATOR, THE HUB BROKE OFF. THE HUB DETACHED DURING REMOVAL OF THE DILATOR FROM THE INTRODUCER. NO INTERVENTION WAS REQUIRED - THE PHYSICIAN CONTINUED WITH THE PROCEDURE AS THE DILATOR WAS ALREADY OUT OF THE SHEATH, AND THE SHEATH WAS PLACED CORRECTLY. NO RESISTANCE WAS NOTED WHEN REMOVING THE INTRODUCER FROM THE SHEATH. THE DEVICE WAS NOT BENT EXCESSIVELY PRIOR TO THE DETACHMENT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7086250 ↗
• InjuryNov 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT INTRODUCER DEVICE. THERE WAS NO DAMAGE TO PACKAGING OF THE INTRAKIT INTRODUCER. THE DEVICE WAS REMOVED FROM PACKAGING AS PER IFU AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. RESISTANCE WAS ENCOUNTERED WHEN THE DILATOR WAS INSERTED INTO THE SHEATH UP UNTIL THE LAST 1CM- ONLY BEFORE THE HUB WAS CONNECTED DID THE RESISTANCE INCREASE SIGNIFICANTLY. THE DILATOR HUB BROKE CLEANLY OFF THE DILATOR WHEN THE PHYSICIAN TRIED TO REMOVE THE DILATOR FROM THE SHEATH WHILE IT WAS STILL IN THE PATIENT'S WRIST. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/ DELIVERY. THE DEVICE WAS NOT BENT EXCESSIVELY PRIOR TO THE DETACHMENT. NO COMPONENTS REMAIN IN THE PATIENT. NO PATIENT INJURY REPORTED. THE DEVICE WAS REPLACED WITH A NON MDT DEVICE.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 6999297 ↗
• InjuryNov 2, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT INTRODUCER DEVICE. THERE WAS NO DAMAGE TO THE INTRAKIT PACKAGING AND THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/ DELIVERY. RESISTANCE WAS ENCOUNTERED WHEN THE DILATOR WAS INSERTED INTO THE SHEATH UP UNTIL THE LAST 1CM- ONLY BEFORE THE HUB WAS CONNECTED DID THE RESISTANCE INCREASE SIGNIFICANTLY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DILATOR IN THE USUAL MANNER FROM THE SHEATH WHILST IT WAS INSERTED IN THE PATIENT'S WRIST. AS THE PHYSICIAN WENT TO REMOVE THE DILATOR, THE DILATOR HUB BROKE CLEANLY OFF. THE DEVICE WAS NOT BENT EXCESSIVELY PRIOR TO THE DETACHMENT. NO COMPONENTS REMAIN IN THE PATIENT. NO PATIENT INJURY REPORTED. THE DEVICE WAS REPLACED WITH A NON MDT DEVICE.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 6996618 ↗
• MalfunctionOct 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING AN INTRAKIT DEVICE, RIGHT ARM ACCESS WAS APPLIED. IT IS REPORTED THAT WHEN REMOVING THE DILATOR FROM THE SHEATH WHILE IN THE PATIENT, THE HUB OF THE DILATOR BROKE OFF. THE WIRE WAS REMOVED SEPARATELY, NOT AT THE SAME TIME AS THE DILATOR. THE PHYSICIAN HAD TO PULL DEVICE OUT AND PRESS ON THE ARTERY. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6961776 ↗
• MalfunctionOct 4, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT DEVICE. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. EVENT THROUGH THE SHEATH HAD BEEN PROPERLY HYDRATED , THE CONSULTANT FOUND IT DIFFICULT TO INSERT DILATOR AND SHEATH INTO THE RADIAL ARTERY. EXCESSIVE FORCE WAS USED DURING INSERTION. WHEN THE CONSULTANT BENT THE DILATOR AT THE 30 DEGREE ANGLE AND REMOVED THE DILATOR FROM THE SHEATH, THE DILATOR HUB BROKE OFF AND LEFT THE DILATOR INSIDE THE SHEATH. THE SHEATH HAD TO BE REMOVED AND REPLACED WITH A COMPETITOR SHEATH. NO INJURY CAUSED TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6914471 ↗
• MalfunctionSep 15, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT DEVICE. NO DAMAGE NOTED TO INTRAKIT PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU, INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. THE DILATOR HUB BROKE WHEN DISENGAGING FROM THE SHEATH HOWEVER DID NOT TOTALLY DETACH. THE SHEATH WAS REMOVED DUE TO THE DILATOR ISSUE. THE WIRE THAT CAME WITH THE KIT HAD BEEN REMOVED BEFORE THE HUB BROKE. NO RESISTANCE ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. RIGHT ARM RADIAL ACCESS USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6868055 ↗
• MalfunctionAug 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN INTRAKIT TRANSRADIAL ACCESS KIT. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. THE ACCESS SITE WAS THE RIGHT RADIAL ARTERY. EXCESSIVE FORCE WAS USED DURING INSERTION. ONCE IN POSITION, THE REQUIRED FORCE WAS USED TO DISENGAGE THE DILATOR FROM THE SHEATH. THE PHYSICIAN PULLED BACK THE WIRE AND DILATOR BUT REALISED THAT THE HUB HAD SNAPPED OFF THE DILATOR LEAVING THE BLUE DILATOR STUCK INSIDE THE SHEATH INSIDE THE PATIENTS RIGHT RADIAL ARTERY. THE DR. THEN HAD TO RE-WIRE THE BROKEN DILATOR STUCK INSIDE SHEATH TO MAINTAIN RADIAL ACCESS AND THEN REMOVE THE SHEATH AND DILATOR AND REPLACE WITH A NEW SHEATH AND DILATOR. NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816420 ↗
• InjuryJul 21, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE AN INTRAKIT INTRODUCER DURING A PROCEDURE USING A RADIAL APPROACH. NO ISSUES WERE NOTED DURING PREP. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. DURING THE PROCEDURE, IT IS REPORTED THAT WHILE TILTING THE DILATOR, THE HUB BROKE OFF WHEN TRYING TO REMOVE IT FROM THE SHEATH. NO EXCESSIVE FORCE WAS USED. FORCEPS WERE THEN USED TO REMOVE THE REST OF THE DILATOR. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6731633 ↗