R2P MISAGO SXR08060RRecalls & 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 04987350727664), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Separation” (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
- Premature Separation1
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.
MalfunctionAug 27, 2020Premature Separation; Premature Separation
THE USER FACILITY REPORTED THAT THE MD PLACED THE MISAGO DEVICE IN RIGHT EXTERNAL ARTERY VIA CONTRALATERAL APPROACH FROM LEFT FEMORAL ARTERY (LFA). A DESTINATION GUIDING SHEATH USED WITH A GLIDEWIRE ADVANTAGE 035. INITIAL PLACEMENT OF GORE VBX STENT IN THE DISTAL EXTERNAL ARTERY VIA THE RIGHT FEMORAL ARTERY ACCESS, FOLLOWED BY MISAGO PLACEMENT VIA LFA. UPON POST DILATION STENT WAS NOTED TO HAVE SEPARATED. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED; ADDITIONAL STENT PLACED COVERING THE MISAGO STENT. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. DISEASED LIMB: RIGHT; LOCATIONS: OTHER ILIAC; CALCIFICATION: MODERATE; TORTUOUSNESS: MILD; TASC II CLASSIFICATION: TYPE C; LESION LENGTH APPROXIMATELY(MM):40; % DIAMETER STENOSIS: 75; REFERENCE VESSEL DIAMETER APPROXIMATELY (MM): 7. SITE OF ACCESS/PUNCTURE AND APPROACH: FEMORAL ARTERY CONTRALATERAL. LESION TREATMENT HISTORY: PRE-DILATATION: YES; POST-DILATATION: YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10459817 ↗
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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