Roadsaver Carotid Atery Stent RDS-0830-143RX-MVIRecalls & reported problems
Microvention, Inc. · Roadsaver Carotid Atery Stent · Class 3 · Implant
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 00811425020937), received between Oct 21, 2025 and Oct 21, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2025Break; Break
AS REPORTED: TRANS FEMORAL RT. CARTOID STENT PROCEDURE. ROADSAVER CARTOID STENT SYSTEM NOSE CONE SEPARATION FROM CATHETER DURING REMOVAL OF THE SYSTEM FROM THE BODY. THE NOSE CONE WAS SEPARATED AT THE TUOHY HEMOSTASIS VALVE WE CONCLUDED AND WITHOUT KNOWING THE BALLOON WAS INSERTED AND THE NOSE CONE WAS WEDGED INTO THE NOSE OF THE BALLOON CATHETER. UPON REVIEWING THE IMAGES, WE SAW THE NOSE CONE TRAVELING UP AS THE BALLOON WAS ADVANCED AND AFTER POST DILATION WHEN THE BALL WAS REMOVED THE NOSE CONE CAME WITH IT. IT WAS EVENTUALLY REMOVED FROM THE BODY SUCCESSFULLY. PATIENTS POST PROCURE OUTCOME WAS SUCCESSFUL. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23354259 ↗
Other Stent, carotid devices
- Neuroguard IEP® System NG-0740-140-2Contego Medical, Inc. · Stent, Carotid2 recalls32 reports
- Neuroguard IEP® System NG-NV-6-40Contego Medical, Inc. · Stent, Carotid2 recalls9 reports
- Neuroguard IEP® System NG-NV-7-40Contego Medical, Inc. · Stent, Carotid2 recalls8 reports
- ENROUTE Transcarotid Stent SR-0940-CSSilk Road Medical, Inc. · Stent, Carotid1 recall5 deaths58 reports
- Neuroguard IEP® System NG-0640-140-2Contego Medical, Inc. · Stent, Carotid2 recalls7 reports
- ENROUTE Transcarotid Stent SR-1040-CSSilk Road Medical, Inc. · Stent, Carotid1 recall3 deaths56 reports
- CGuard Prime Carotid Stent System CND0840Inspire M.D Ltd · Stent, Carotid1 recall1 death41 reports
- CGuard Prime Carotid Stent System CND0940Inspire M.D Ltd · Stent, Carotid1 recall31 reports
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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