R2P MISAGO SXR07100RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987350727626), received between Jul 2, 2020 and Aug 22, 2023 — classified as 2 injuries, 4 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE DOCTOR DEPLOYED THE MISAGO IN THE SUPERFICIAL FEMORAL ARTERY (SFA). WHEN DEPLOYING HE FELT A LITTLE RESISTANCE AFTER ABOUT 1/2 WAY THROUGH DEPLOYING. UNDER FLUOROSCOPY IT LOOKED LIKE IT WAS BUNCHED UP, BUT AS HE CONTINUED TO SCAN, HE REALIZED THAT THE PROXIMAL END WAS NEARLY IN THE ILIAC. OUR ASSUMPTION WAS THAT IT MAY HAVE GOTTEN CAUGHT ON THE END OF A CATHETER OR SOMETHING THAT CAUSED IT TO ELONGATE. THE PATIENT CONDITION WAS GOOD. THE OUTCOME OF THE PROCEDURE WAS GOOD. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUL2023: ADDITIONAL DEVICES WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600352 ↗
• MalfunctionApr 21, 2022Stretched; Activation Problem; Stretched; Activation Problem

  THE USER FACILITY REPORTED THAT THE MISAGO DEVICE INVOLVED WAS USED TO STENT VIA RADIAL APPROACH WITH A SLENDER DESTINATION IN PLACE. DURING DEPLOYMENT, IT WAS VERY HARD TO TURN THE THUMB WHEEL. THERE WAS A LOT OF TORQUE STORED IN THE CATHETER. ALTHOUGH THE THUMB WHEEL WAS CONTINUALLY ROLLED BACKWARD, THE STENT WOULD NOT DEPLOY. AFTER THE STENT RELEASED IT WAS APPROXIMATELY 30 MILLIMETERS LONGER THAN IT SHOULD HAVE BEEN. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS COMPETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 24 MAR 2022: THIS WAS A PERIPHERAL ARTERIAL DISEASE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165995 ↗
• InjuryMar 23, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE USER FACILITY REPORTED THAT AFTER THE INITIAL PROCEDURE WAS PERFORMED USING THE MISAGO DEVICE INVOLVED, THE PATIENT RETURNED ON (B)(6) 2021, WITH NUMBNESS AND A COLD LEG. A REINTERVENTION IDENTIFIED RESTENOSIS AT THE SITE. THERE WAS ALSO A SUPERA USED IN THE SAME LESION, NUMBER ONE. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LEFT LIMB WAS DISEASED. THE LOCATION WAS AT THE SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL. THE REFERENCE VESSEL DIAMETER WAS APPROXIMATELY 6 MILLIMETERS. THE LESION TREATMENT WAS PRE-DILATION. THE SITE OF ACCESS/PUNCTURE AND APPROACH WAS AT THE RADIAL ARTERY RETROGRADE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28 FEB 2022: THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2020. THE PROCEDURE WAS A RADIAL TO PERIPHERAL RUNOFF AND INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 04 MAR 2022: THE INITIAL PROCEDURE WAS SUCCESSFUL. THERE WAS 10 PERCENT OR LESS STENOSIS IN EACH LESION. THE REINTERVENTION PERFORMED WAS A COVERED STENT TO ILIAC (WHERE THE MISAGO WAS PLACED). THE SUPERA USED IN LESION

  Patient problems: Numbness; Restenosis

  MAUDE report 13861632 ↗
• InjuryMar 23, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE USER FACILITY REPORTED THAT AFTER THE INITIAL PROCEDURE WAS PERFORMED USING THE MISAGO DEVICE INVOLVED, THE PATIENT RETURNED ON (B)(6)2021, WITH NUMBNESS AND A COLD LEG. A REINTERVENTION IDENTIFIED RESTENOSIS AT THE SITE. THERE WAS ALSO A SUPERA USED IN THE SAME LESION, NUMBER ONE. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LEFT LIMB WAS DISEASED. THE LOCATION WAS AT THE SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL. THE REFERENCE VESSEL DIAMETER WAS APPROXIMATELY 6 MILLIMETERS. THE LESION TREATMENT WAS PRE-DILATION. THE SITE OF ACCESS/PUNCTURE AND APPROACH WAS AT THE RADIAL ARTERY RETROGRADE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2020. THE PROCEDURE WAS A RADIAL TO PERIPHERAL RUNOFF AND INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE INITIAL PROCEDURE WAS SUCCESSFUL. THERE WAS 10 PERCENT OR LESS STENOSIS IN EACH LESION. THE REINTERVENTION PERFORMED WAS A COVERED STENT TO ILIAC (WHERE THE MISAGO WAS PLACED). THE SUPERA USED IN LESION

  Patient problems: Numbness; Restenosis

  MAUDE report 13861610 ↗
• MalfunctionNov 27, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT THE MISAGO THUMB WHEEL WAS JAMMED ON THE DEVICE. SINCE THE DEVICE WAS CONTAMINATED THE DEVICE WAS DISCARDED. THIS OCCURRED PRE-TREATMENT. THE DEVICE NEVER WENT INTO THE PATIENT'S BODY. THERE WERE NO ISSUES. THE CASE WAS SUCCESSFUL. PATIENT CONDITION WAS FINE. THE PROCEDURE OUTCOME WAS EXCELLENT. MISAGO SPECIFIC INFORMATION: THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. LOCATION WAS THE SFA (SUPERFICIAL FEMORAL ARTERY). DISEASED LIMB, RIGHT SFA. THERE WERE NO CALCIFICATIONS OR TORTUOSITY. OTHER EQUIPMENT OR DEVICES WERE USED WITH THE INVOLVED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 09NOVEMBER2021: THEY USED ANOTHER STENT, SECOND SAME DEVICE, WITH NO ISSUES (TO COMPLETE STENTING AS DESCRIBED). PATIENT WAS STABLE, CASE SUCCESSFUL. THE THUMBWHEEL LOCK COULD NOT BE PUSHED IN TO CREATE THE MECHANISM TO BE RELEASED. THE THUMBWHEEL WAS UNABLE TO BE CLICKED, ROTATED. NOTHING WAS JAMMED IN THE GAP BETWEEN THE HANDLE AND THE THUMBWHEEL. THE ONLY ISSUE WAS THE THUMBWHEEL WOULD NOT UNLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879751 ↗
• MalfunctionJul 2, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P MISAGO WAS USED DURING THE PROCEDURE; AND THE DOCTOR STATED THAT IT FORESHORTENED. HE HAD TO USE A SECOND MISAGO STENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION WAS STABLE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6). 2020, THE PROCEDURE TAKING PLACE AT THE TIME WAS A REVASCULARIZATION OF LOWER EXTREMITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SECOND STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223438 ↗