R2P MISAGO SXR07080RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350727602), received between Jul 18, 2022 and Aug 16, 2022 — classified as 2 malfunctions.

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

Recent adverse event reports

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

• MalfunctionAug 16, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED MISAGO DEVICE FOLDED UP ON ITSELF WHILE BEING DEPLOYED. THE DEVICE WAS AN 80-MILLIMETER STENT AND ENDED UP BEING ABOUT 40 MILLIMETERS ONCE FULLY DEPLOYED. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LEFT LIMB WAS DISEASED. THE LOCATION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE CALCIFICATION WAS MODERATE AND THERE WAS NO TORTUOSITY. THE LESION'S LENGTH WAS APPROXIMATELY 80MM. THE VESSEL'S DIAMETER WAS APPROXIMATELY 7MM. THE LESION WAS PRE-DILATED AND POST DILATED. THE SITE OF ACCESS/PUNCTURE AND APPROACH WAS FEMORAL ARTERY CONTRALATERAL, RETROGRADE. THE PATIENT CONDITION WAS GOOD. THE OUTCOME OF THE PROCEDURE WAS GOOD. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 01 AUG 2022: THE PROCEDURE PERFORMED WAS A LEFT LOWER LEG ANGIOGRAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231851 ↗
• MalfunctionJul 18, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE RADIAL TO PERIPHERAL ACCESS ON THE RIGHT ARM WAS USED TO TREAT A RIGHT ILIAC LESION. ACCESS WAS ACHIEVED WITH A 6 FR. GLIDESHEATH SLENDER AND A RADIAL COCKTAIL WAS ADMINISTERED. A 350 CM .035 R2P GLIDEWIRE WAS INSERTED WITH A 120 CM 4 FR. GLIDECATH TO THE SITE OF THE LESION AND THE WIRE WAS USED TO CROSS THE ILIAC LESION, WITHOUT ISSUE. THE GLIDECATH WAS REMOVED AND A 6 MM X 40 MM EVERCROSS BALLOON WAS ADVANCED OVER THE .035 GLIDEWIRE TO THE LESION AND USED TO PREDILATE THE ILIAC LESION. THE BALLOON WAS REMOVED AND A 6 MM X 60 MM R2P MISAGO STENT WAS PLACED ON THE GLIDEWIRE AND ADVANCED TO THE R2P DESTINATION SLENDER SHEATH. AS THE STENT WAS ADVANCED INTO THE HUB OF THE SHEATH, THE PROXIMAL PART OF THE STENT SHAFT WHERE THE STENT ENDS AND TRANSITIONS TO THE SHAFT, BECAME KINKED. THE STENT WAS INSPECTED, AND THE PHYSICIAN DETERMINED THAT THE PULLY WIRES ON THE STENT SHAFT WERE KINKED, AND HE DECIDED NOT TO USE THE STENT. THE STENT WAS REMOVED OFF THE WIRE AND A NEW R2P MISAGO STENT, 7 MM X 80 MM WAS OPENED AND ADVANCED THROUGH THE SHEATH TO THE PROXIMAL PORTION OF THE ILIAC LESION, HOWEVER, IT WOULD NOT FULLY CROSS THE LESION AND COULD NOT BE DEPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037048 ↗