Misago® SXR06080LRecalls & reported problems
Terumo Corporation · MISAGO RX Self-expanding Peripheral Stent · Class 3 · Implant
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 04987350722102), received between Nov 10, 2015 and Nov 10, 2015 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2015Appropriate Device Problem Term/Code Not Available
THE USER FACILITY REPORTED THAT DURING AN SFA CASE, WHEN THE MISAGO DEVICE WAS DEPLOYED, IT LOOKED POTENTIALLY ELONGATED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) ACCESS WAS GAINED AT THE FEMORAL ARTERY CONTRALATERAL; (2) THE PHYSICIAN STARTED TO PULL BACK ON THE DELIVERY SYSTEM PRIOR TO COMPLETION OF STENT DEPLOYMENT; (3) THE PHYSICIAN CONTINUED TO DEPLOY BY CLICKING THE THUMBWHEEL AS THE SYSTEM WAS BEING REMOVED; (4) THE PHYSICIAN NOTED WHEN THE CASE WAS COMPLETED THAT THE STENT LOOKED ELONGATED BUT COULD NOT CONFIRM UNDER FLOURO; (5) IT WAS THEN DECIDED TO USE A VIABAHN COVERED STENT; (6) THE STENT WAS DEPLOYED THROUGHOUT THE ENTIRE LESION WITHIN ALL STENTS THAT WERE DEPLOYED PREVIOUSLY; (7) THE FINAL RUN WAS TAKEN AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS; (8) THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND (9) THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5213191 ↗
Other Stent, Superficial Femoral Artery devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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