MICRO-STICK SETMICRO-STICK SET MR190411Recalls & reported problems
Medical Components, Inc. · 4F (1.0MM ID) X 9CM STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE WITH RADIOPAQUE TIP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908085440), received between Aug 23, 2017 and Jan 8, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
- Knotted1
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Material Fragmentation
WHILE ATTEMPTING TO GAIN ARTERIAL ACCESS USING THE GUIDEWIRE, IT WAS NOTED THAT THE ARTERY WAS OCCLUDED WITH PLAGUE. WHEN THE SURGEON ATTEMPTED TO WITHDRAW THE GUIDEWIRE, IT APPEARED TO HAVE BECOME HOOKED ON THE PLAGUE, CAUSING THE GUIDEWIRE TO STRETCH. IN THE PROCESS, THE OUTER COATING OF THE GUIDEWIRE BECAME DISLODGED, AND A FRAGMENT OF THE COATING REMAINED WITHIN THE VESSEL.
Patient problems: Foreign Body In Patient
MAUDE report 24001921 ↗MalfunctionAug 23, 2017Knotted; Device Handling Problem; Knotted; Device Handling Problem
AT THE TIME THE GUIDEWIRE WAS BEING INTRODUCED IT GOT STUCK AND IT DIDN'T ADVANCE. WHEN THEY MANAGED TO TAKE IT OUT, THEY SAW THERE WAS A KNOTTED IN IT AT THE TIP OF THE WIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6813951 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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