MICRO-STICK SETMICRO-STICK SET DMR190521Recalls & reported problems
Medical Components, Inc. · 5F (1.0MM ID) X 9CM5F (1.0MM ID) REGULAR MICRO-STICK® INTRODUCER SETINTRODUCER SET WITH NITINOL GUIDEWIREWITH NITIN WITH RADIOPAQUE TIPWITH RADIOPAQ · Class 2
Data updated Oct 18, 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 00884908142426), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2022Break; Break
DEVICE WAS USED INITIALLY IN ORDER TO GAIN ACCESS TO THE PATIENTS GRAFT ACCESS. THE DEVICE NEEDLE AND WIRE WENT IN SMOOTHLY, HOWEVER WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE HE NOTICED A PORTION OF THE WIRE WAS BROKEN OFF AND THE REMAINDER OF THE WIRE WAS LEFT IN THE PATIENTS ACCESS. THIS WAS VERIFIED UNDER FLUOROSCOPY. THE LOCATION OF THE WIRE IN THE PATIENT IS STABLE AT ITS LOCATION BUT IS AT RISK FOR MIGRATION AND POTENTIAL SERIOUS HEALTH RISKS. AT THIS TIME THE PATIENT HAS NOT BEEN HARMED.
Patient problems: Foreign Body In Patient
MAUDE report 14715983 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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