R2P MISAGO SXR08040RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350727640), received between Apr 27, 2023 and Nov 7, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT WHILE LOADING THE STENT ONTO THE GUIDEWIRE, THE STENT WAS ACCIDENTALLY RELEASED DUE TO THE ROLLER BALL BEING DEPRESSED UPON OPENING THE PACKAGE. A SECOND MISAGO STENT WAS USED SUCCESSFULLY IN THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AND NO BLOOD LOSS. THE PROCEDURE PERFORMED WAS A LEG AV FISTULA. ADDITIONAL INFORMATION RECEIVED ON 15 OCT 2024: THEY DID NOT DEPRESS THE ROLLER BALL BUT WERE UNSURE OF WHAT OCCURRED BETWEEN OPENING THE PACKAGE AND STARTING TO USE IT. THIS INCIDENT DID NOT CAUSE ANY HARM DURING THE PROCEDURE OR TO THE PATIENT. THE STENT NEVER ENTERED THE SHEATH OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627005 ↗
• MalfunctionApr 27, 2023Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED A RADIAL CASE WITH AN INTERVENTION OF THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). WHEN THE DOCTOR WENT TO PASS THE STENT INTO THE INVOLVED DESTINATION SLENDER GUIDING SHEATH THERE WAS RESISTANCE AT THE HUB OF THE SHEATH. THE PROXIMAL END OF THE STENT WAS EXAMINED AND NOTICED THAT THE END OF THE STENT WAS OUT OF THE PROTECTIVE SHEATH. THE MARKERS HAD STARTED TO FLARE, AND THE THUMBWHEEL HAD NOT BEEN DEPRESSED OR ROLLED BACKWARDS. THE PROXIMAL STENT EDGE HAD SHIFTED PRIOR TO THE INTRODUCTION INTO THE GUIDING SHEATH. THE THUMBWHEEL HAD BEEN VERIFIED THAT IT WAS NOT ALTERED BY THE TECH DURING PREP OR PRE DEPLOYMENT. THE STENT NEVER MADE IT INTO THE PATIENT AS IT MET RESISTANCE IN THE SHEATH. THE CASE WAS COMPLETED WITH ANOTHER STENT. THE PATIENT WAS IN FINE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LESION LOCATION WAS AT THE SFA, WITH MODERATE CALCIFICATION AND NO TORTUOUSNESS. THE LESION LENGTH WAS APPROXIMATELY 30MM, WITH 80% DIAMETER STENOSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826930 ↗