Sofia 6F-125cm STR DA6125STRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812636020426), received between May 13, 2021 and Jul 1, 2021 — classified as 1 death, 1 injury.

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 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.

• InjuryJul 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT FOR A CAROTID T OCCLUSION, A SOFIA CATHETER FELT JAMMED IN A CATHETER WHEN RETRACTED. ON A FOLLOW-UP ANGIOGRAPHIC RUN, A DISTAL MARKER WAS NOTED IN THE INTERNAL CAROTID ARTERY. ON INSPECTION, THE TIP OF THE SOFIA WAS OBSERVED TO HAVE BEEN DETACHED. THE TIP OF THE SOFIA WAS RETRIEVED WITH A STENT TRIEVER. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105141 ↗
• DeathMay 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A THROMBECTOMY THE MICROCATHETER WAS ADVANCED WITH RESISTANCE DUE TO CERVICAL KINKING. THE MICROCATHETER WAS ADVANCED THROUGH THE SOFIA DURING THE SECOND MANEUVER, HOWEVER, RESISTANCE WAS AGAIN ENCOUNTERED DISTALLY. RECANALIZATION WAS ACHIEVED, BUT THERE WAS REMAINING OCCLUSION DISTALLY WITH COMPLETE CLOSURE OF THE VESSEL. THE SURGEON REPORTED A THREAD-LIKE, ELONGATED ELASTIC MATERIAL IN THE DISTAL ICA, WHICH HE DESCRIBED AS A THROMBUS. THE MATERIAL WAS INSPECTED BY THE HOSPITAL AND DETERMINED TO BE "ORGANIC," BUT ITS ORIGIN HAS NOT YET BEEN EVALUATED BY THE MANUFACTURER. IT WAS REPORTED THAT THE PATIENT LATER PASSED AWAY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11822560 ↗