R2P MISAGO SXR06120RRecalls & reported problems
Terumo Corporation · MISAGO RX Self-expanding Peripheral Stent · Class 3 · Implant
All models of R2P MISAGO (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350727725), received between Mar 10, 2020 and Mar 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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.
MalfunctionMar 10, 2020Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT THE R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT WAS USED DURING THE PROCEDURE. THE STENT WAS USED TO COVER A DISSECTION POST ATHERECTOMY WITH A CSI DEVICE AND PTA WITH AN 018 CROSTELLA R2P BALLOON. THE MISAGO 6X120 R2P STENT WAS INSERTED TO COVER THE DISSECTION AND GAVE GOOD TISSUE OVERLAP. WHEN THE STENT WAS DEPLOYED, IT WAS NOTICEABLY FORESHORTENED UNDER FLUOROSCOPY. WHEN THEY INSERTED POST DILATION, 018 CROSTELLA R2P 6X100 BALLOON WAS INSERTED TO DILATE THE STENT TO 6, THE BALLOON WAS NOTICEABLY ALMOST THE SAME SIZE OF THE STENT AND THERE SHOULD HAVE BEEN MORE STENT THAN BALLOON. THE LESION LENGTH WAS APPROXIMATELY 40 MM AND THE PERCENTAGE OF DIAMETER STENOSIS WAS 85%. THE REFERENCE VESSEL DIAMETER WAS APPROXIMATELY 5 MM. THE SITE OF ACCESS IS THE RADIAL ARTERY AND THE APPROACH WAS RETROGRADE. PRE AND POST DILATATION WERE DONE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS GOOD. THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9812344 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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