Misago® SXR06150LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04987350722140), received between Oct 27, 2015 and Apr 21, 2016 — classified as 4 injuries, 2 malfunctions.

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

• InjuryApr 21, 2016Break; Break

  THE USER FACILITY REPORTED TIP DAMAGE ON THE MISAGO DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A FRACTURE WAS FOUND ON THE DISTAL TIP OF THE MISAGO DEVICE DURING AN SFA PROCEDURE; THE STENT OF THE ACTUAL DEVICE WAS DEPLOYED; WHEN TRYING TO PULL THE ACTUAL DEVICE CAREFULLY, THE DISTAL TIP BECAME CAUGHT IN A CALCIFIED PART OF THE LESION INSIDE THE STENT; TORQUE AND PUSHING FORCES WERE APPLIED AT THE SAME TIME; THE ACTUAL SAMPLE MOVED TO THE DISTAL SIDE; SUBSEQUENTLY, BOTH TORQUE AND PULLING FORCES WERE APPLIED AT THE SAME TIME AND THE ACTUAL SAMPLE BECAME STUCK AGAIN; FINALLY THE DEVICE WAS PULLED WITH FORCE OUT OF THE PATIENT; UNDER AN ANGIOGRAPHY AFTER ANOTHER IMPLANTATION OF A MISAGO DEVICE, POOR BLOOD FLOW WAS NOTED; A FOREIGN SUBSTANCE WAS FOUND ATTACHED TO THE INVOLVED GUIDE WIRE; THE ACTUAL SAMPLE WAS CHECKED AND FOUND THAT THE DISTAL TIP WAS MISSING; THE DISTAL TIP THAT WAS LEFT IN THE PATIENT WAS RETRIEVED WITH THE USE OF SNARE; AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5593849 ↗
• InjuryApr 14, 2016Fracture; Fracture

  THE USER FACILITY REPORTED STENT ELONGATION IN THE MISAGO DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: TWO SXR0615OL'S WERE DEPLOYED IN THE LEFT SFA VIA CONTRALATERAL ACCESS; THE FIRST WAS PLACED DISTAL AND THE SECOND WAS PLACED PROXIMAL THROUGH THE PROXIMAL END OF THE DISTAL OR FIRST STENT; BOTH DEPLOYED WITHOUT ISSUE AND NO DEFORMATION WAS NOTED POST DILATION THROUGH ANGIOGRAPHY; THE DOCTOR THEN PERFORMED PEDAL ACCESS OF THE LEFT TIBIAL ARTERY TO CROSS A LESION FROM BELOW; ONCE ACROSS THE LESION, THE DOCTOR EMPLOYED A SNARE CATHETER FROM ABOVE; THE DOCTOR ENCOUNTERED A PROBLEM WHEN ADVANCING THE SNARE; THERE WAS RESISTANCE UPON ENTERING THE DISTAL MISAGO THAT WAS PLACED FIRST; IT APPEARED THE STENT HAD BEEN COMPLETELY FRACTURED AND MOVED DISTAL; UPON FURTHER INSPECTION AT HIGH RESOLUTION THE STENT WAS INTACT, JUST ELONGATED WITH CRIMPING ABOVE THAT AREA; FURTHER TREATMENT CONSISTED OF ACCESSING THE TRUE LUMEN OF THE STENT WITH AT PTA BALLOON AND THEN PLACING A LIFESTENT ACROSS THE AREA OF ELONGATION; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5578795 ↗
• MalfunctionApr 14, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED DEPLOYMENT ISSUES IN THE MISAGO DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE APPROACH WAS MADE FROM THE BRACHIAL ARTERY TO PLACE THE STENT IN THE STENOSED SFA-DISTAL; THE CUSTOMER CLICKED THE THUMBWHEEL 3 - 5 TIMES; THE STENT DID NOT COME OUT OF THE SLIDING PART; THE CUSTOMER PULLED THE ACTUAL SAMPLE BACK AND RE-ADVANCED IT INTO THE LESION; THE STENT HAD ALREADY STARTED TO BECOME DEPLOYED WITH THE DISTAL SEGMENT HAVING BEEN ELONGATED; THE STENT WAS DEPLOYED THERE AND REACHED DFA DUE TO THE ELONGATION BY 15-20CM; AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5578660 ↗
• InjuryDec 15, 2015Break

  THE USER FACILITY REPORTED THAT THE MISAGO STENT RUPTURED DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: TWO 6X100 ZILVER PTX'S WERE USED IN PROXIMAL SFA AND A 6X150 MISAGO WAS USED IN DISTAL SFA PRE-DILATED WITH A 4MM PTA. AFTER DEPLOYMENT, ALL STENTS WERE POST-DILATED. THERE WAS AN AREA IN THE SECOND ZILVER THAT NEEDED ADDITIONAL DILATION, A 5X200 WAS USED AGAIN AND TAKEN TO 22 ATM. THE MISAGO STENT RUPTURED WHERE THE MUSTANG WAS. THE MISAGO STENT SEPARATED INTO TWO PARTS, IT WAS REPORTED THAT IT LOOKED LIKE IT WAS CUT IN HALF. THERE WAS THE FIRST PART OF THE MISAGO AND THEN AN AREA WHERE NO STENT REMAINED, WHICH MEANS IT SHORTENED AFTER BREAKING IN HALF AND THEN THERE WAS STENT AGAIN. DUE TO THE SEPARATION OF THE STENT THERE BECAME AN AREA OF ABOUT 10 MM THAT WAS NO LONGER COVERED BY MISAGO. THE ENTIRE COMPROMISED AREA WAS COVERED WITH A VIABAHN AND THE BALLOON WAS CORRECTLY SIZED. THE PROCEDURE WAS COMPLETED. THE PATIENT IS REPORTED IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5298107 ↗
• InjuryNov 4, 2015Break

  THE USER FACILITY REPORTED TIP SEPARATION ON THE MISAGO DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) THE BLUE SILICONE TIP OF THE MISAGO DEVICE BECAME SEPARATED AND THE STENT COULD NOT BE USED; (2) THE SILICONE TIP IS IN THE PATIENT AT THE DEAD END IN THE THROMBUS OF THE SUPERFICIAL FEMORAL ARTERY; (3) THE SURGEON CONFIRMED THAT THE TIP DOES NOT HAVE ANY CONSEQUENCE ON THE PATIENTS HEALTH; AND (4) ANOTHER STENT WAS IMPLANTED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5201883 ↗
• MalfunctionOct 27, 2015Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE MISAGO DEVICE DEPLOYED WHILE THE THUMB-WHEEL WAS LOCKED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: THE APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY; A 90 CM-LONG GUIDING SHEATH DESTINATION, WAS USED CONCURRENTLY WITH THE MISAGO DEVICE; TREATMENT WAS FOR THE RIGHT SFA; THE ACTUAL SAMPLE WAS ADVANCED INTO THE DESTINATION DEVICE; WHEN THE MISAGO DEVICE CAME OUT OF THE DISTAL END OF THE DESTINATION, WITH SOME RESISTANCE, IT WAS FOUND TO HAVE ALREADY DEPLOYED BY ABOUT TWO STRUTS WITHOUT THE USER UNLOCKING THE THUMB-WHEEL; AND THE ACTUAL SAMPLE WAS DRAWN BACK THROUGH THE DESTINATION AND CHANGE OUT TO ANOTHER MISAGO DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5180976 ↗