Misago® SXR07120LRecalls & 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 04987350722249), received between Aug 22, 2016 and Aug 22, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE USER FACILITY REPORTED THAT THE MISAGO STENT SHORTENED UPON DEPLOYMENT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE STENT HAD TO BE REPOSITIONED THREE TIMES; UPON DEPLOYMENT THE STENT THEN FORESHORTENED BY OVER 4CM AFTER IT FLOWERED AND WAS PLACED; PLACED CONTRA-LATERALLY IN THE LEFT SFA OVER A BENTSON .035 WIRE, NON-TORTUOUS, PRE-DILATED SEGMENT; THE LANDING ZONE WAS COMPLETELY MISSED BECAUSE OF ALL THE MOVEMENT; A SECOND STENT HAD TO BE PLACED; BLOOD LOSS WAS LESS THAN 250CC; THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER PLACEMENT OF THE SECOND STENT; AND THE PATIENT'S CONDITION WAS REPORTED AS EXCELLENT.
Patient problems: Blood Loss
MAUDE report 5893590 ↗
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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