Sofia 6F-131cm STR DA6131STRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812636020846), received between Jul 1, 2021 and Jul 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A MALE PATIENT WITH A LEFT M1 THROMBOEMBOLIC OCCLUSION WAS TREATED BY ENDOVASCULARLY. AN 8F GUIDE CATHETER WAS PLACED IN THE MODERATELY ELONGATED LEFT CERVICAL ICA THAT HAD SHOWN ATHEROSCLEROTIC WALL CHANGES ON THE INITIAL CT. THE PROXIMAL SURFACE OF THE CLOT WAS EASILY REACHED WITH THE SOFIA DIRECT ASPIRATION, HOWEVER WAS NOT SUFFICIENT. THE CLOT COULD BE PASSED WITH A MICROCATHETER, WIRE AND STENT RETRIEVER. STANDARD RETRIEVAL UNDER CONTINUOUS ASPIRATION ON THE SOFIA DISLODGED THE CLOT, HOWEVER, IT WAS NOT POSSIBLE TO FULLY RETRIEVE THE STENT INTO THE SOFIA. DURING THE ATTEMPTS TO RETRIEVE, INTENSE AXIAL LOAD WAS TRANSMITTED TO THE SOFIA RESULTING IN RESISTANCE DURING ADVANCEMENT AND RETRACTION ATTEMPTS AND THE DEVICE BECOMING DAMAGED. THE SOLUTION WAS THAT THE THROMBX WAS DISMANTLED, ITS INTRODUCTION WIRE CUT OUTSIDE THE PATIENT, THE PROXIMAL BASKET AND ALL CATHETERS WERE REMOVED. THE INTRODUCER WIRE WAS THEN USED TO DELIVER A NEW MICROCATHETER AND A DIFFERENT INTERMEDIATE CATHETER WHICH ALLOW TO RETRIEVE THE DISTAL BASKET TOGETHER WITH THE CLOT, RESULTING IN A TICI 3 RECANALIZATION. THE CERVICAL ICA SHOWED A DISSECTION IN A LOCATION THAT WAS EXPOSED TO THE

  Patient problems: Vascular Dissection

  MAUDE report 12104381 ↗