R2P MISAGO SXR07150RRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04987350727787), received between Apr 7, 2020 and Jan 14, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT DURING A RIGHT LEG ANGIOGRAPHY WITH LEFT COMMON FEMORAL ARTERY (CFA) ACCESS THROUGH A 6 FRENCH (6F) 45CM DESTINATION SHEATH PLACED IN THE RIGHT CFA, A 6MM SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (POP) USING A 0.014 INCH (014) / 300CM GUIDEWIRE (GWA). AFTER POST-IMAGING, THE DOCTOR PLACED A 6MM X 150MM MISAGO STENT OVER THE 014/300CM GWA IN THE SFA/POP ARTERY. THE DOCTOR THEN DECIDED TO PLACE ANOTHER STENT IN THE SFA, PROXIMAL TO THE PREVIOUS STENT. USING THE SAME WIRE, HE ATTEMPTED TO PLACE A 7MM X 150MM STENT. DURING DEPLOYMENT, THE STENT WOULD NOT "FLOWER." IT WAS NOTICED THAT THE WIRE WAS LOOPED IN THE SFA ABOVE THE RAPID PORT. AFTER ATTEMPTING TO STRAIGHTEN THE WIRE, THE DOCTOR PULLED THE WIRE COMPLETELY OUT OF THE MISAGO STENT AND SHEATH. AT THIS POINT, HE DECIDED TO REMOVE THE STENT SYSTEM. THE STENT WOULD NOT ADVANCE INTO THE 6F SHEATH, SO HE DECIDED TO REMOVE BOTH THE SHEATH AND THE STENT SYSTEM. THE SHEATH CAME OUT EASILY, AND AFTER PULLING THE SHAFT OF THE STENT, IT CAME OUT AS WELL. GROIN PRESSURE WAS HELD FOR 20 MINUTES. AFTER PEDAL PULSES WERE TAKEN AND GROIN PULSES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154698 ↗
• InjuryFeb 20, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE 7 X 150 MISAGO WAS DEPLOYED IN A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT DIFFICULTY. THE MEDICAL DOCTOR (MD) THEN TRIED TO PASS AN 8 X 80 BALLOON OVER THE GWA .035 AND THE PROXIMAL EDGE OF THE MISAGO WOULD NOT ALLOW THE BALLOON TO CROSS. THE MD TRIED SMALLER BALLOONS ON THE .035 PLATFORM, AND NONE WOULD PASS THE PROXIMAL PORTION OF THE STENT. EVENTUALLY THE MD CHANGED OUT THE .035 SYSTEM FOR AN .018 PLATFORM AND WAS ABLE TO GET A .018 BALLOON ACROSS THE PROXIMAL PORTION OF THE STENT AND INFLATE AND EXPAND THE STENT AND ALLOWED HIM TO COMPLETE THE CASE. THE MD HAD TO USE ADDITIONAL .018 PLATFORM EQUIPMENT AND AN ADDITIONAL 7 X 40 MISAGO TO DEPLOY INSIDE OF THE PROXIMAL PORTION OF THE 7 X 150 MISAGO TO ENSURE THAT IT WOULD STAY OPEN. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID RESULT IN PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. THE PATIENT'S MEDICAL HISTORY WAS PERIPHERAL ARTERY DISEASE (PVD), CORONARY ARTERY DISEASE (CAD). 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 25 JAN 20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743154 ↗
• InjuryFeb 20, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE 7 X 150 MISAGO WAS DEPLOYED IN A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT DIFFICULTY. THE MEDICAL DOCTOR (MD) THEN TRIED TO PASS AN 8 X 80 BALLOON OVER THE GWA .035 AND THE PROXIMAL EDGE OF THE MISAGO WOULD NOT ALLOW THE BALLOON TO CROSS. THE MD TRIED SMALLER BALLOONS ON THE .035 PLATFORM, AND NONE WOULD PASS THE PROXIMAL PORTION OF THE STENT. EVENTUALLY THE MD CHANGED OUT THE .035 SYSTEM FOR AN .018 PLATFORM AND WAS ABLE TO GET A .018 BALLOON ACROSS THE PROXIMAL PORTION OF THE STENT AND INFLATE AND EXPAND THE STENT AND ALLOWED HIM TO COMPLETE THE CASE. THE MD HAD TO USE ADDITIONAL .018 PLATFORM EQUIPMENT AND AN ADDITIONAL 7 X 40 MISAGO TO DEPLOY INSIDE OF THE PROXIMAL PORTION OF THE 7 X 150 MISAGO TO ENSURE THAT IT WOULD STAY OPEN. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID RESULT IN PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. THE PATIENT'S MEDICAL HISTORY WAS PERIPHERAL ARTERY DISEASE (PVD), CORONARY ARTERY DISEASE (CAD). 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 25 JAN 20

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742472 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE MISAGO DEVICE INVOLVED WAS USED DURING A PERIPHERAL INTERVENTION OF A CHRONIC TOTAL OCCLUSION SUPERFICIAL FEMORAL ARTERY (CTO) (SFA) USING A 6 FRENCH 45-CENTIMETER DESTINATION VIA THE CONTRA LATERAL APPROACH. THE PHYSICIAN CROSSED WITH A 035 ADVANTAGE/035 NAVICROSS. AFTER CROSSING THE LESION, ORBITAL ATHERECTOMY WAS PERFORMED USING A CARDIOVASCULAR SYSTEM, INC. (CSI) DEVICE. THE VESSEL WAS PRE-DILATED USING AN ABBOTT ARMADA BALLOON. AFTER PRE DILATION, A 7/150 MISAGO STENT WAS DEPLOYED IN THE SFA SUCCESSFULLY. ONCE THE STENT CATHETER WAS REMOVED FROM THE PATIENT'S BODY, THE PHYSICIAN NOTICED A FRACTURE AROUND THE DEPLOYMENT HANDLE. THE FRACTURE AROUND THE DEPLOYMENT HANDLE DID NOT CAUSE ANY ISSUES DEPLOYING THE STENT. THE STENT WAS THEN POST DILATED USING A BALLOON. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE TYPE OF TREATMENT WAS PERIPHERAL INTERVENTION ANGIOPLASTY/ATHERECTOMY/STENT. THE LESION TREATMENT HISTORY: DISEASED LIMB RIGHT SFA, MODERATE CALCIFICATION, NO TORTUOUSNESS, TASC II CL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428713 ↗
• MalfunctionNov 21, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE MISAGO STENT INVOLVED WOULD NOT DEPLOY. THE OPERATOR DEPLOYED THE STENT FEMORAL; HOWEVER, THE OUTER BLUE SLEEVE WAS HELD WHICH PREVENTED THE STENT FROM DEPLOYING. THE STENT WAS REMOVED, AND A NEW ONE WAS USED WITHOUT HOLDING THE SLEEVE; IT DEPLOYED SUCCESSFULLY. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 01 NOV 2022: THE PROCEDURE PERFORMED WAS A LOWER EXTREMITY (LE) ANGIOGRAPHY. THERE WAS NO REPORTED DAMAGE TO THE SHEATH PRIOR TO USE. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 03 NOV 2022: OTHER EQUIPMENT WAS USED WITH THE STENT DURING PROCEDURE; HOWEVER, IT WAS FEMORAL ACCESS, AND THE PHYSICIAN USUALLY USES GLIDEWIRE ADVANTAGE AND DESTINATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834960 ↗
• MalfunctionMay 3, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A RIGHT ILIAC AND SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION THAT TOOK APPROXIMATELY 4 HOURS TO CROSS. ONCE THE CHRONIC TOTAL OCCLUSION (CTO) WAS CROSSED, A 6MM BALLOON WAS USED, THEN THE 7MM X 150MM MISAGO INVOLVED WAS USED TO STENT. THE LANDING ZONE, THE SFA AND PROFUNDA JUNCTION, WAS MISSED WITH THE STENT. THE PHYSICIAN PRESUMES THE SFA OCCLUSION WILL MOST LIKELY OCCUR DUE TO HAVING MISSED THE OSTIAL LESION. THE PATIENT WAS FINE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE RIGHT LIMB WAS DISEASED. THERE WAS SEVERE CALCIFICATION AND NO TORTUOUSNESS. ADDITIONAL INFORMATION WAS RECEIVED ON 12 APR 2022: THE STENT WAS USED WITH A 6FR SHEATH. THE STENTING WAS COMPLETED, BUT THE STENT FORESHORTENED SIGNIFICANTLY. THE STENT WAS 150MM AND SHORTENED TO APPROXIMATELY 130MM. ADDITIONAL INFORMATION WAS RECEIVED ON 15 APR 2022: THE STENT WAS LEFT AS IS AND THE OSTIAL SEGMENT OF THE SFA WAS LEFT WITHOUT STENT. THE PHYSICIAN PRESUMES THAT SINCE THE OSTIAL SEGMENT WAS LEFT UNTREATED, IT WILL MOST LIKELY SHUTDOWN DUE TO IT BEING A CTO AND SINCE THERE WAS NO STENT KEEPING THE ARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268277 ↗
• MalfunctionApr 4, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE MISAGO STENT INVOLVED WAS ADVANCED OVER AN 014 VIPER WIRE AFTER THE VESSEL HAS BEEN PREPPED WITH AN ATHERECTOMY DEVICE AND PRE-DILATED WITH A 6X150 BALLOON. THE 7X150 MISAGO WAS ADVANCED DOWN SMOOTHLY. THE DOCTOR UNLOCKED THE THUMB WHEEL AND STARTED TO ROLL IT BACK SLOWLY. AFTER SEVERAL CLICKS, THE ENTIRE STENT CAME OUTSIDE OF THE BODY. THE DEVICE STARTED TWISTING AND TORQUING VERY BADLY, THE DOCTOR HAD STOPPED AND ASKED WHAT WAS WRONG WITH THE STENT. THE DISTAL END OF THE STENT WAS ALSO MOVING BACK MORE THAN NORMAL. THE DOCTOR WAS INSTRUCTED TO KEEP DEPLOYING. AFTER THE STENT FLOWERED OPEN, THE TENSION RELEASED ON THE STENT, AND IT DEPLOYED. THIS WAS PRESUMED TO NOT BE A GOOD DEPLOYMENT AND THE DOCTOR WAS NOT HAPPY WITH IT. THE STENT WAS SHORTENED TO ABOUT A LENGTH OF 140 MILLIMETERS, THIS WAS KNOWN BECAUSE THE BALLOON WAS 150 MILLIMETERS POST DILATING THE STENT. THE PATIENT WAS IN GOOD CONDITION. THE PROCEDURE WAS A SUCCESS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 09 MAR 2022: THE PROCEDURE PERFORMED WAS A SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY/STENT. THE PATIENT WAS IN

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 13998845 ↗
• InjuryMar 18, 2022Break; Activation Problem; Break; Activation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED MISAGO DEVICE WAS USED TO TREAT A HEAVILY DISEASED SUPERFICIAL FEMORAL ARTERY (SFA) FROM THE BRACHIAL ARTERY. THE DOCTOR HAD TO CROSS THROUGH AN AORTIC GRAFT AND A BALLOON EXPANDABLE STENT IN THE OSTIAL SFA. WHEN THE DOCTOR ROLLED BACK THE WHEEL ON THE MISAGO, THE SHAFT OF THE STENT STARTED TO CURL UP/SPIRAL, BUT THE STENT HAD NOT STARTED TO FLOWER. THE DOCTOR PULLED THE WHOLE STENT BACK. THE TIP OF THE STENT WITH THE DISTAL MARKERS STAYED IN THE SFA, BUT THE REST OF THE DEVICE WAS STUCK IN THE DESTINATION 6 FR 90CM SHEATH. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 03 MAR 2022: THE TIP WAS NOT REMOVED FROM THE PATIENT. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13806901 ↗
• InjuryMar 18, 2022Break; Activation Problem; Break; Activation Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED MISAGO DEVICE WAS USED TO TREAT A HEAVILY DISEASED SUPERFICIAL FEMORAL ARTERY (SFA) FROM THE BRACHIAL ARTERY. THE DOCTOR HAD TO CROSS THROUGH AN AORTIC GRAFT AND A BALLOON EXPANDABLE STENT IN THE OSTIAL SFA. WHEN THE DOCTOR ROLLED BACK THE WHEEL ON THE MISAGO, THE SHAFT OF THE STENT STARTED TO CURL UP/SPIRAL, BUT THE STENT HAD NOT STARTED TO FLOWER. THE DOCTOR PULLED THE WHOLE STENT BACK. THE TIP OF THE STENT WITH THE DISTAL MARKERS STAYED IN THE SFA, BUT THE REST OF THE DEVICE WAS STUCK IN THE DESTINATION 6 FR 90CM SHEATH. THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 03 MAR 2022: THE TIP WAS NOT REMOVED FROM THE PATIENT. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13806894 ↗
• MalfunctionSep 22, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P MISAGO WAS USED DURING THE PROCEDURE. THE STENT MOVED FORWARD INITIALLY DURING DEPLOYMENT, AND THEN BUNCHED UP IN MULTIPLE SPOTS DURING DEPLOYMENT. THEY WERE USING IT THROUGH A 6F 11CM PINNACLE SHEATH WITH AN ANTEGRADE APPROACH TO THE SFA. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. LESION TREATMENT HISTORY: DISEASED RIGHT LIMB; LOCATION: SFA; CALCIFICATION: MODERATE; TORTUOUSNESS: MILD. LESION LENGTH, DIAMETER, STENOSIS %: LESION LENGTH APPROXIMATELY (MM)180; % DIAMETER STENOSIS: 90; REFERENCE VESSEL DIAMETER APPROXIMATELY (MM)6. SITE OF ACCESS/PUNCTURE AND APPROACH: FEMORAL ARTERY IPSILATERAL AND RETROGRADE. LESION TREATMENT HISTORY: PRE-DILATATION: YES, AND POST-DILATATION: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566479 ↗
• MalfunctionJun 1, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE USER FACILITY REPORTED THAT THE DOCTOR SAW FORESHORTENING OF HE INVOLVED R2P MISAGO STENT POST DIL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE STENT FORESHORTENED BY 1-2 CM. THE PROCEDURE WAS A LOWER EXTREMITY REVASCULARIZATION. THE PATIENT'S CONDITION WAS STABLE. A DIFFERENT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS IMPLANTED, JUST NOT THE WAY IT WAS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104724 ↗
• MalfunctionJun 1, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE USER FACILITY REPORTED THAT THE DOCTOR SAW FORESHORTENING OF HE INVOLVED R2P MISAGO STENT POST DIL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 11MAY2020. THE STENT FORESHORTENED BY 4 CM. THE PROCEDURE WAS A LOWER EXTREMITY REVASCULARIZATION. THE PATIENT'S CONDITION WAS STABLE. A DIFFERENT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS IMPLANTED, JUST NOT THE WAY IT WAS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10104723 ↗
• MalfunctionApr 7, 2020Activation Problem; Activation Problem

  THE USER FACILITY REPORTED THAT INVOLVED MISAGO WAS USED DURING THE PROCEDURE. THE STENT DEPLOYMENT WHEEL BECAME TIGHT. THE STENT SHAFT SHOWED IT WAS TIGHTENING UP BECAUSE IT WAS BUILDING TENSION IN THE SHAFT THAT COULD BE SEEN. THE DOCTOR WAS GOING TO PULL IT OUT, AND THEN THE STENT STARTED TO DEPLOY, THEY CONTINUED TO DEPLOY THE STENT AND IT WAS DEPLOYED. DUE TO THE ISSUE, IT WAS DEPLOYED IN THE WRONG SPOT, AND THEY HAD TO GET ANOTHER STENT TO DEPLOY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD. THE SITE OF ACCESS WAS THE FEMORAL ARTERY IPSILATERAL. LESION TREATMENT HISTORY: PRE-DILATION AND POST DILATION. LESION LENGTH APPROXIMATELY 50MM, DIAMETER IN STENOSIS 75 %, REFERENCE VESSEL DIAMETER APPROXIMATELY 6MM. THE PATIENT'S LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. LESION TREATMENT HISTORY: DE NOVO. TASC II CLASSIFICATION: TYPE A. DISEASED LIMB: LEFT; LOCATION: SFA; CALCIFICATION: MILD. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932441 ↗