SilverSpeedTM 103-0602-200Recalls & reported problems
Micro Therapeutics, Inc. · 103-0602-200 SILVERSPEED14 GWIRE ATH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536004566), received between Oct 26, 2018 and Mar 3, 2019 — classified as 1 injury, 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Hemorrhage, Cerebral1
- Neurological Deficit/Dysfunction1
- 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.
InjuryMar 3, 2019Break; Break
MEDTRONIC RECEIVED REPORT THAT THE SLIVERSPEED 014 GUIDEWIRE TIP BROKE DURING NORMAL CATHETERIZATION. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE WHILE IN THE ANATOMY AND OBSTRUCTED THE MIDDLE CEREBRAL ARTERY (MCA). ATTEMPTS TO RETRIEVE THE SEPARATED PIECE WITH A STENT AND SNARE WERE UNSUCCESSFUL. A HEMORRHAGE WAS IDENTIFIED IN THE MCA THAT WAS ALLEGED TO HAVE BEEN CAUSED BY THE GUIDEWIRE TIP. A COIL WAS USED TO STOP THE HEMORRHAGE. HOWEVER, AT THE END OF THE PROCEDURE, THE MCA WAS CLOSED / OCCLUDED WHICH WAS NOT INTENDED BY THE USER. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ANEURYSM. POST THE INTERVENTION, THE PATIENT DID HAVE NEUROLOGICAL DETERIORATION. THE SILVERSPEED WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE SILVERSPEED GUIDEWIRE TIP WAS SHAPED BY THE USER. THE CATHETER WAS FLUSHED AND THE GUIDEWIRE WAS HYDRATED AS INDICATED IN THE IFU. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. THERE WAS NO RESISTANCE WHEN THE GUIDEWIRE WAS ADVANCED IN THE CATHETER OR THE ANATOMY.
Patient problems: Hemorrhage, Cerebral; Neurological Deficit/Dysfunction
MAUDE report 8384935 ↗MalfunctionOct 26, 2018Fracture; Fracture
MEDTRONIC RECEIVED REPORT OF SILVERSPEED GUIDEWIRE RESISTANCE IN AN ECHELON CATHETER PRIOR TO A PROCEDURE. AFTER BECOMING STUCK, THE SILVERSPEED WAS WITHDRAWN FROM THE ECHELON. IT WAS NOTED THAT THE SILVERSPEED TIP WAS BENT AND "COMPLETELY DAMAGED." THE SILVERSPEED WAS REPLACED WITH AN XPEDION 14 TO CONTINUE THE PROCEDURE. THE ECHELON CATHETER HAD BEEN FLUSHED AND THE GUIDEWIRE HAD BEEN HYDRATED AS INDICATED IN THE IFU. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8009591 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 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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