Misago® SXR07150LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350722263), received between Mar 31, 2016 and Aug 31, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THROMBOSED STENTS AFTER THEY WERE PLACED IN THE PATIENT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR USED TWO 7X150 MISAGO STENTS; ANGIOGRAPHIC RESULT AFTER STENT PLACEMENT SHOWED THE STENTS TO BE THROMBOSED; THE PATIENT WAS DRIPPED WITH TPA OVERNIGHT AND TREATED SEVERAL DAYS LATER WITH A KEESLER AFB; THE PATIENT HAD SURGICAL INTERVENTION FOR ''COMPARTMENT SYNDROME'' RELATED TO THE ISCHEMIA OF THE LEG WHILE MAJOR ARTERIES WERE THROMBOSED; AND A TECH AT KEESLER REPORTED THAT UNDER ANGIOGRAPHY THE STENTS HAD RESTENOSED AT THE EDGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5916969 ↗
• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THROMBOSED STENTS AFTER THEY WERE PLACED IN THE PATIENT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR USED TWO 7X150 MISAGO STENTS; ANGIOGRAPHIC RESULT AFTER STENT PLACEMENT SHOWED THE STENTS TO BE THROMBOSED; THE PATIENT WAS DRIPPED WITH TPA OVERNIGHT AND TREATED SEVERAL DAYS LATER WITH A (B)(6); THE PATIENT HAD SURGICAL INTERVENTION FOR ''COMPARTMENT SYNDROME'' RELATED TO THE ISCHEMIA OF THE LEG WHILE MAJOR ARTERIES WERE THROMBOSED; AND A TECH AT (B)(6) REPORTED THAT UNDER ANGIOGRAPHY THE STENTS HAD RESTENOSED AT THE EDGES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5916968 ↗
• InjuryMar 31, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED A FAILURE IN THE THUMBWHEEL OF THE MISAGO DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE ACTUAL DEVICE WAS USED IN AN SFA DISTAL PROCEDURE FOR A VERY TORTUOUS LESION; THE STENT REACHED THE LESION WITHOUT ANY DIFFICULTY; WHEN THE CUSTOMER CLICKED THE THUMBWHEEL A STRANGE RESISTANCE WAS NOTICED AND IT DID NOT TURN SMOOTHLY; AFTER TEN CLICKS THE STENT WOULD NOT DEPLOY; CONTINUED CLICKING OF THE THUMBWHEEL WITH SOME FORCE, THE CUSTOMER MANAGED TO PLACE THE STENT IN THE LESION; ANOTHER STENT WAS ADDED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5537707 ↗