Misago® SXR07060LRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350722188), received between Feb 23, 2016 and Mar 17, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE USER FACILITY REPORTED THAT THE MISAGO DEVICE WOULD NOT FULLY DEPLOY. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PROCEDURE WAS FOR A PERIPHERAL CASE; THE MISAGO DEVICE WAS PREPARED; THE TIP WAS FLUSHED WITH SALINE BUT IT DID NOT DRIP OUT OF THE CATHETER; THE STENT WAS LOADED OVER THE .035 GLIDEWIRE; RESISTANCE WAS FELT IMMEDIATELY WHEN GOING THROUGH THE VALVE OF THE 30CM COOK SHEATH; THE DOCTOR TOOK AN IMAGE, THE STENT WAS PARTIALLY DEPLOYED; THE DOCTOR DECIDED TO FINISH DEPLOYING THE STENT, AND IT CAME OUT TWISTED AT BOTH ENDS; AND (THE DOCTOR ATTEMPTED TO BALLOON THE STENT, AND DEPLOYED A 100CM STENT THROUGH THE TWISTED STENT AND BALLOONED SEVERAL TIMES TO FIX THE TWISTED STENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5506788 ↗MalfunctionFeb 23, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
THE USER FACILITY REPORTED THAT THE MISAGO DEVICE DEPLOYED INSIDE OF THE DESTINATION DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING DEPLOYMENT OF THE MISAGO STENT IT STARTED TO DRIFT PROXIMALLY FROM THE INITIAL POSITION; THE DEVICE WAS MOVE BACK INTO THE INVOLVED DESTINATION AND DEPLOYED; THE STENT WAS STRETCHED TO APPROXIMATELY 100MM POSSIBLY DUE TO SOME PULLING FORCE TO THE MISAGO DEVICE; THE STENT WAS LEFT IMPLANTED IN THE PATIENT; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS NOT IMPACTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5453529 ↗
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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