Sofia EX 5F - 115cm STR ISC5115ST-MVIRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429101582), received between Oct 16, 2020 and Sep 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionSep 9, 2024Complete Blockage; Complete Blockage

  WHILE PREPARING THE SOFIA DEVICE ON THE BACK TABLE, THE MICROCATHETER WOULD NOT ADVANCE THROUGH THE SOFIA EX. THE OPERATOR THEN ATTEMPTED TO ADVANCE JUST A WIRE, BUT THAT ALSO WOULD NOT ADVANCE. THE SOFIA WAS NOT USED AND WAS REPLACED WITH A COMPETITOR DEVICE. ADDITIONAL INFORMATION FROM THE POST-EVALUATION REPORT REVEALED THAT A PTFE LINER WAS FOUND TO BE OCCLUDING THE LUMEN, WHICH IS IN LINE WITH THE DESCRIBED ADVANCEMENT ISSUE IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20177479 ↗
• MalfunctionApr 27, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, THE ANATOMY WAS VERY TORTUOUS AND IT WAS DECIDED TO EXCHANGE A SOFIA EX CATHETER FOR A LONGER ONE. WHILE REMOVING THE SOFIA EX OVER THE EXCHANGE WIRE, THE PHYSICIAN NOTICED THE TIP OF THE SOFIA EX WAS DAMAGED AND MISSING ITS DISTAL MARKER BAND. AS HE MANIPULATED THE WIRE TO INTRODUCE THE NEW CATHETER, THEY NOTICED THE DISTAL MARKER WAS OUTSIDE OF THE SHEATH AND WRAPPED AROUND THE EXCHANGE WIRE. THERE WAS NO INTERVENTION OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735558 ↗
• InjuryOct 16, 2020Break; Break

  IT WAS REPORTED THAT DURING USE IN THE PATIENT, THE TIP OF THE CATHETER DETACHED DURING RETRACTION INTO THE INFINITY SHEATH. AN ATTEMPT WAS MADE TO RETRIEVE THE TIP WITH A STENT RETRIEVER, BUT IT WAS UNSUCCESSFUL. THE TIP REMAINS IN THE PATIENT. THERE WAS NO REPORTED SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10694063 ↗