R2P MISAGO SXR06100RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350727541), received between Jun 28, 2022 and Nov 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT A 6X100 MISAGO WAS DEPLOYED IN DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AREA WHERE SOME PLAQUE DISSECTION WAS PRESENT. UPON DEPLOYMENT THE PROXIMAL END OF THE STENT APPEARED TO BE CRIMPED. THIS MALFORMATION OF DEPLOYMENT WAS NOT FLOW LIMITING, HOWEVER IT WAS A CONCERN FOR THE DOCTOR AFTER PLACEMENT. HE FURTHER INVESTIGATED AND SHOWED UNDER INTRAVASCULAR ULTRASOUND (IVUS) THAT THE FLUOROSCOPY IMAGE WAS CONFIRMED, AND THE TOP OF THE STENT WAS CRIMPED. THE DOCTOR WAS NOT SATISFIED WITH THE STENT AND REALIGNED THE MISAGO WITH A 6X40 ZILVER PTX STENT. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS DISEASED LIMB. SITE OF THE PUNCTURE WAS THE FEMORAL ARTERY CONTRALATERAL VIA ANTEGRADE APPROACH. THE LESION LENGTH 100, WITH A 5MM VESSEL DIAMETER. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239352 ↗
• InjuryOct 25, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PATIENT NEEDED A RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO MILD POPLITEAL INTERVENTION. AN ATHERECTOMY WAS DONE WITH A DRUG COATED BALLOON (DCB) TO MID POP TO DISTAL RIGHT SFA, AND STENT FROM MID TO DISTAL SFA. THE ACCESS WAS A CUT DOWN TO THE RIGHT PROXIMAL SFA WITH A SHORT 7 FRENCH SHEATH ANTEGRADE POSITIONED. THE VESSEL WAS 6MM IN DIAMETER AND 150MM IN LENGTH WAS NEEDED. WHEN THE STENT WAS DEPLOYED, THE STENT DID NOT ELONGATE. AFTER DEPLOYMENT, IT SHORTENED. THE STENT LENGTH WAS NOT ENOUGH, AND ANOTHER MISAGO STENT WAS PLACED PROXIMALLY. HOWEVER, IT WAS FORESHORTENED ALSO. THE STENT LENGTH WAS 100MM. THE DOCTOR USED A THIRD STENT TO COVER THE LENGTH TO THE MID SFA. THE STENT WAS A ZILVER BALLOON EXPANDING STENT. THE PATIENT'S VESSEL WAS FULLY OPPOSED, AND FLOW WAS NOT LIMITED. PRIOR TO THE INTERVENTION THE VESSEL WAS A CHRONIC TOTAL OCCLUSION (CTO). THE CASE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESSFUL INTERVENTION OF RIGHT SFA. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LESION TREATMENT HISTORY WAS DE NOVO. THE RIGHT LIMB WAS DISEASED. THE CALCIFICATION WAS MODERATE. TORTUOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668463 ↗
• InjuryJun 28, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT A 6X100 MISAGO WAS DEPLOYED IN DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AREA WHERE SOME PLAQUE DISSECTION WAS PRESENT. UPON DEPLOYMENT THE PROXIMAL END OF THE STENT APPEARED TO BE CRIMPED. THIS MALFORMATION OF DEPLOYMENT WAS NOT FLOW LIMITING, HOWEVER IT WAS A CONCERN FOR THE DOCTOR AFTER PLACEMENT. HE FURTHER INVESTIGATED AND SHOWED UNDER INTRAVASCULAR ULTRASOUND (IVUS) THAT THE FLUOROSCOPY IMAGE WAS CONFIRMED, AND THE TOP OF THE STENT WAS CRIMPED. THE DOCTOR WAS NOT SATISFIED WITH THE STENT AND REALIGNED THE MISAGO WITH A 6X40 ZILVER PTX STENT. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS DISEASED LIMB. SITE OF THE PUNCTURE WAS THE FEMORAL ARTERY CONTRALATERAL VIA ANTEGRADE APPROACH. THE LESION LENGTH 100, WITH A 5MM VESSEL DIAMETER. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849203 ↗