R2P MISAGO SXR07120RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350727763), received between Jun 7, 2025 and Jun 7, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation Failure” (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

Recent adverse event reports

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

• InjuryJun 7, 2025Material Fragmentation; Device Dislodged or Dislocated; Activation Failure; Material Fragmentation; Device Dislodged or Dislocated; Activation Failure

  THE USER FACILITY DURING A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION VIA CONTRALATERAL FEMORAL ACCESS, A PHYSICIAN SUCCESSFULLY DEPLOYED A 7MM X 150CM MISAGO STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A .035 ROSEN WIRE. A SECOND STENT, A 7MM X 120CM MISAGO, WAS THEN PREPARED FOR IMPLANTATION. ACCORDING TO THE TECHNOLOGIST, THE STENT WAS FLUSHED WITH A SYRINGE PRIOR TO USE. UPON INITIATING DEPLOYMENT BY ROLLING THE WHEEL ON THE DELIVERY SYSTEM, THE PROXIMAL SHAFT OF THE MISAGO DELIVERY SYSTEM BENT OR KINKED AT A 90-DEGREE ANGLE AT THE STRAIN RELIEF OF THE HANDLE, WHICH PREVENTED FULL DEPLOYMENT OF THE STENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PARTIALLY DEPLOYED STENT, BUT IT BEGAN TO FRAGMENT WITHIN THE PATIENT. THE SHEATH HAD TO BE REMOVED DUE TO THE COMPROMISED STENT. WIRE ACCESS WAS MAINTAINED, AND A NEW SHEATH WAS INTRODUCED. A FRAGMENT OF THE STENT WAS LOCATED WITHIN THE TISSUE TRACT AT THE ARTERIOTOMY SITE AND WAS SUCCESSFULLY REMOVED BEFORE THE NEW SHEATH WAS PLACED. THE PHYSICIAN PROCEEDED TO PERFORM ANGIOPLASTY ON THE SFA AND DEPLOYED A PROTEGE STENT. HOWEVER, A FRAGMENT OF THE MISAGO STENT REMAINED LODGED IN THE ILIAC ARTERY. THE TECHNOLOGIST REPORTED THAT

  Patient problems: Foreign Body Embolism; Pain; Reduced Blood Flow

  MAUDE report 22162298 ↗
• InjuryJun 7, 2025Material Fragmentation; Device Dislodged or Dislocated; Activation Failure; Material Fragmentation; Device Dislodged or Dislocated; Activation Failure

  THE USER FACILITY DURING A LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION VIA CONTRALATERAL FEMORAL ACCESS, A PHYSICIAN SUCCESSFULLY DEPLOYED A 7MM X 150CM MISAGO STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A .035 ROSEN WIRE. A SECOND STENT, A 7MM X 120CM MISAGO, WAS THEN PREPARED FOR IMPLANTATION. ACCORDING TO THE TECHNOLOGIST, THE STENT WAS FLUSHED WITH A SYRINGE PRIOR TO USE. UPON INITIATING DEPLOYMENT BY ROLLING THE WHEEL ON THE DELIVERY SYSTEM, THE PROXIMAL SHAFT OF THE MISAGO DELIVERY SYSTEM BENT OR KINKED AT A 90-DEGREE ANGLE AT THE STRAIN RELIEF OF THE HANDLE, WHICH PREVENTED FULL DEPLOYMENT OF THE STENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PARTIALLY DEPLOYED STENT, BUT IT BEGAN TO FRAGMENT WITHIN THE PATIENT. THE SHEATH HAD TO BE REMOVED DUE TO THE COMPROMISED STENT. WIRE ACCESS WAS MAINTAINED, AND A NEW SHEATH WAS INTRODUCED. A FRAGMENT OF THE STENT WAS LOCATED WITHIN THE TISSUE TRACT AT THE ARTERIOTOMY SITE AND WAS SUCCESSFULLY REMOVED BEFORE THE NEW SHEATH WAS PLACED. THE PHYSICIAN PROCEEDED TO PERFORM ANGIOPLASTY ON THE SFA AND DEPLOYED A PROTEGE STENT. HOWEVER, A FRAGMENT OF THE MISAGO STENT REMAINED LODGED IN THE ILIAC ARTERY. THE TECHNOLOGIST REPORTED THAT

  Patient problems: Foreign Body Embolism; Pain; Reduced Blood Flow

  MAUDE report 22162287 ↗