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R2P MISAGO SXR08080RRecalls & 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350727688), received between Apr 28, 2021 and Apr 28, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 28, 2021Material Deformation; Material Deformation

    THE USER FACILITY REPORTED THAT THE MISAGO WAS USED DURING THE PROCEDURE. DURING AN UP AND OVER PERIPHERAL INTERVENTION 6FR RIGHT SIDED ACCESS. WHEN THE STENT WAS DEPLOYED IN THE LEFT EXTERNAL ILIAC ARTERY, IT WAS NOTICED THAT THE DISTAL PORTION APPEARED IRREGULAR AND CRIMPED. IT WAS RELINED WITH AN 8X100 MISAGO STENT AND THE RUNOFF APPEARED FINE. THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ARTERY WAS NOT PREVIOUSLY TREATED. THE LEFT LIMB WAS DISEASED. THE LESION LENGTH WAS APPROXIMATELY 60MM. THE DIAMETER STENOSIS WAS 80 PERCENT. THE APPROXIMATE VESSEL DIAMETER WAS 7MM. THE LOCATION WAS OTHER EXTERNAL ILIAC. THE CALCIFICATION WAS MODERATE. THE TORTUOUSNESS WAS MILD. THE SITE OF ACCESS WAS FEMORAL ARTERY CONTRALATERAL VIA ANTEGRADE. LESION TREATMENT HISTORY: BOTH PRE AND POST DILATION. ADDITIONAL INFORMATION WAS RECEIVED ON 09APR2021. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15APR2021. THE DISTAL END OF THE STENT WAS IRREGULAR AND CRIMPED. AN ADDITIONAL MISAGO WAS PLACED TO COVER THE DAMAGED PART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11738048 ↗
  • InjuryApr 28, 2021Material Deformation; Material Deformation

    THE USER FACILITY REPORTED THAT THE MISAGO WAS USED DURING THE PROCEDURE. DURING AN UP AND OVER PERIPHERAL INTERVENTION 6FR RIGHT SIDED ACCESS. WHEN THE STENT WAS DEPLOYED IN THE LEFT EXTERNAL ILIAC ARTERY, IT WAS NOTICED THAT THE DISTAL PORTION APPEARED IRREGULAR AND CRIMPED. IT WAS RELINED WITH AN 8X100 MISAGO STENT AND THE RUNOFF APPEARED FINE. THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE ARTERY WAS NOT PREVIOUSLY TREATED. THE LEFT LIMB WAS DISEASED. THE LESION LENGTH WAS APPROXIMATELY 60MM. THE DIAMETER STENOSIS WAS 80 PERCENT. THE APPROXIMATE VESSEL DIAMETER WAS 7MM. THE LOCATION WAS OTHER EXTERNAL ILIAC. THE CALCIFICATION WAS MODERATE. THE TORTUOUSNESS WAS MILD. THE SITE OF ACCESS WAS FEMORAL ARTERY CONTRALATERAL VIA ANTEGRADE. LESION TREATMENT HISTORY: BOTH PRE AND POST DILATION. ADDITIONAL INFORMATION WAS RECEIVED ON 09APR2021. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15APR2021. THE DISTAL END OF THE STENT WAS IRREGULAR AND CRIMPED. AN ADDITIONAL MISAGO WAS PLACED TO COVER THE DAMAGED PART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11738043 ↗

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Sources and updates

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