Misago® SXR08060LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350722300), received between Mar 17, 2016 and Dec 24, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• MalfunctionDec 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 13DEC2019. AT THE TIME OF SURGERY AND INITIAL POST OP THE PATIENT WAS WELL. THERE HAS BEEN NO FOLLOW UP SINCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517145 ↗
• InjuryMar 17, 2016Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE MISAGO DEVICE APPEARED TO BE FRACTURED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PHYSICIAN PUT IN A MISAGO STENT ON (B)(6) 2016; THE SUPERIOR FEMORAL ARTERY WAS VERY CALCIFIED AND THE SFA WAS PRETTY LARGE; THE PATIENT WAS BROUGHT BACK ON (B)(6) 2016 TO PLACE A SUPERA STENT IN THE POPLITEAL ARTERY; THE PHYSICIAN NOTICED THAT THE MISAGO STENT APPEARED TO BE FRACTURED; THE PHYSICIAN REALIGNED THE MISAGO STENT WITH AN ICAST STENT AND A VIABAHN; THE FLOW DOWN THE LEG APPEARED TO BE GOOD; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED AS DOING GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5507146 ↗