InTRAkit™ INT6F23C4Recalls & reported problems
Medtronic, Inc. · INTRO INT6F23C4 INTRAKIT 6F 5PK · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169712294), received between Aug 9, 2017 and Aug 9, 2017 — classified as 1 malfunction.
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN INTENDED TO USE AN INTRAKIT ACCESS KIT. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER THE IFU WITH NO ISSUES. DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES. THE DEVICE WAS PROPERLY HYDRATED. IT IS REPORTED THAT THE DILATOR GREEN HUB DETACHED FROM ITS SHEATH, A RADIAL APPROACH WAS USED. NO RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE DILATOR INTO THE SHEATH DURING PREP. NO EXCESSIVE FORCE USED. NO RESISTANCE NOTED WHEN ATTEMPTING TO REMOVE THE INTRODUCER FROM THE SHEATH. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776864 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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