R2P MISAGO SXR06040RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350727480), received between Jun 16, 2020 and May 22, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS IN A RADIAL TO PERIPHERAL CASE IN WHICH HE WAS GOING TO PLACE A 6 X 40 MISAGO IN THE SUPERFICIAL FEMORAL ARTERY (SFA). HE WAS HAVING TROUBLE INTRODUCING THE STENT CATHETER INTO THE SHEATH. WHEN HE LOOKED, THE STENT HAD UNSHEATHED IN THE HUB OF THE DESTINATION SLENDER. THE PHYSICIAN HAD TO REMOVE THE HUB OF THE SHEATH IN ORDER TO REMOVE THE STENT. THE TECH MADE SURE THE RELEASE WHEEL HAD NOT BEEN PUSHED DOWN. HE PUSHED IT AND IT CLICKED, INDICATING THAT IT HAD NOT BEEN ENGAGED WHILE UPON ENTERING THE SHEATH. THE PATIENT (PT) DID NOT RECEIVE A STENT ON THIS DAY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 02APR2024: THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 25APR2024: WHILE INTRODUCING THE STENT INTO THE DESTINATION, IT WOULD NOT INTRODUCE AND WHEN THE PHYSICIAN LOOKED DOWN, THE STENT HAD COME OFF OF THE STENT SHEATH. IT WAS HALFWAY IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368392 ↗
• InjuryApr 23, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS IN A RADIAL TO PERIPHERAL CASE IN WHICH HE WAS GOING TO PLACE A 6 X 40 MISAGO IN THE SUPERFICIAL FEMORAL ARTERY (SFA). HE WAS HAVING TROUBLE INTRODUCING THE STENT CATHETER INTO THE SHEATH. WHEN HE LOOKED, THE STENT HAD UNSHEATHED IN THE HUB OF THE DESTINATION SLENDER. THE PHYSICIAN HAD TO REMOVE THE HUB OF THE SHEATH IN ORDER TO REMOVE THE STENT. THE TECH MADE SURE THE RELEASE WHEEL HAD NOT BEEN PUSHED DOWN. HE PUSHED IT AND IT CLICKED, INDICATING THAT IT HAD NOT BEEN ENGAGED WHILE UPON ENTERING THE SHEATH. THE PATIENT DID NOT RECEIVE A STENT ON THAT DAY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 02APR2024: THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169840 ↗
• MalfunctionJul 5, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE MISAGO WENT IN THE DESTINATION SLENDER DURING RADIAL ACCESS. PHYSICIAN STATED IT FELT TIGHT AS IT MOVED INTO SUBCLAVIAN BYPASS GRAFT. THEY TRIED TO REMOVE THE SHEATH AND IT WAS VERY DIFFICULT TO DO SO. AS THEY REMOVED THE MISAGO CATHETER, THE STENT WAS DEPLOYED OFF OF THE CATHETER ON IT'S OWN. THE PATIENT WAS STABLE AND PROCEDURE OUTCOME WAS SUCCESSFULLY BALLOONED SUPERFICIAL FEMORAL ARTERY (SFA) LESION. THE ARTERY OF THE LOWER EXTREMITY HAD BEEN PREVIOUSLY TREATED. IT WAS A BYPASS FROM THE SUBCLAVIAN TO THE SUPERFICAL FEMORAL ARTERY (SFA) TYPE OF TREATMENT: BYPASS. LESION TREATMENT HISTORY: DE NOVO. DISEASED LIMB: LEFT . LOCATIONS: SFA. CALCIFICATION: MODERATE. TORTUOUSNESS: MILD. LESION LENGTH APPROX.(MM): 40. % DIAMETER STENOSIS: 70. REFERENCE VESSEL DIAMETER APPROX.(MM): 6. SITE OF ACCESS/PUNCTURE & APPROACH: RADIAL ARTERY. LESION TREATMENT HISTORY PRE-DILATATION: YES. POST-DILATATION: NO. ADDITIONAL INFORMATION WAS RECEIVED ON 08 JUN 2023: THE PATIENT WAS POSITIVE FOR ESBL IN HIS URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263539 ↗
• MalfunctionJul 17, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE MISAGO WAS GETTING STUCK AND WOULD NOT CROSS THE LESION, SO THE PHYSICIAN PULLED IT OUT OF BODY, AND IT APPEARED TO HAVE STARTED TO FLOWER WITHOUT ANYONE ATTEMPTING TO DEPLOY. THE PATIENT WAS OK, AND THEY USED ANOTHER MISAGO OF THE SAME SIZE WITH NO ISSUES. SHORT FOCAL LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT IS IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 : THE TYPE OF PROCEDURE WAS BEING PERFORMED WAS A RADIAL ACCESS AORTOGRAM WITH INTERVENTION IN THE SUPERFICIAL FEMORAL ARTERY (SFA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15036805 ↗
• MalfunctionJun 16, 2020Premature Activation; Premature Activation

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P MISAGO WAS USED DURING THE PROCEDURE. THE PHYSICIAN NOTED NEED FOR AN SFA STENT DURING A LOWER EXTREMITY RUNOFF. WHEN TECH WAS PREPARING TO LOAD R2P MISAGO STENT ON TO THE WIRE THEY NOTED THAT THE OUTER DEPLOYMENT SHEATH WAS PULLED BACK SLIGHTLY AND THE DISTAL END OF THE R2P MISAGO WAS EXPOSED AND WAS NEARLY BEGINNING TO DEPLOY. THE STENT WAS NOT INTRODUCED INTO THE BODY. A SECOND STENT WAS OPENED AND USED WITHOUT ISSUE. THERE WAS NO PATIENT COMPLICATION, THE CASE WAS COMPLETED WITHOUT COMPLICATION. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157477 ↗