InTRAkit™ INT5F11C2Recalls & reported problems
Medtronic, Inc. · INTRO INT5F11C2 INTRAKIT 5F 5PK · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169712126), received between Nov 7, 2017 and Nov 7, 2017 — classified as 1 injury.
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
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN INTENDED TO USE AN INTRAKIT DEVICE. THE SHEATH AND DILATOR OF THE INTRAKIT INTRODUCER KIT WERE PREPARED AS ADVISED. IT WAS INSERTED, AND WHEN THE DILATOR WAS DUE TO BE SEPARATED FROM THE SHEATH TO BE REMOVED, THE HUB OF THE DILATOR FELL OFF. THE PHYSICIAN WAS ABLE TO REMOVE THE REMAINING PART OF THE DILATOR WITH A CLIP. THE PHYSICIAN DID NOT HAVE ANY CONCERNS ABOUT THE SHEATH. THE PHYSICIAN LEFT THE SHEATH IN THE PATIENT'S RADIAL ARTERY AND CONTINUED WITH THE CASE. THE PHYSICIAN DID NOT FEEL THAT THE SHEATH WAS DAMAGED AND WAS HAPPY TO CARRY ON.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7006040 ↗
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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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