Skip to content

BOBBY/SOFIA Kit SF6131-B895-USRecalls & reported problems

Microvention, Inc. · BOBBY/SOFIA Kit · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429108574), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation 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

Device problems

  • Deflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 20, 2021Deflation Problem; Deflation Problem

    IT WAS REPORTED THAT THE BALLOON GUIDE CATHETER WAS USED IN A THROMBECTOMY PROCEDURE UP THE LEFT INTERNAL CAROTID ARTERY (ICA) AND WAS PASSED THROUGH FOR ASPIRATION. UPON BALLOON DEFLATION, THE BALLOON SLIGHTLY DEFLATED THEN WOULD NOT DEFLATE ANYMORE AND PHYSICIAN STARTED PULLING BACK BUBBLES IMMEDIATELY ON SYRINGE. THE BALLOON WAS DEFLATED ENOUGH TO PULL BACK INTO AN 8FR SHEATH AND ONCE ENTERED INTO THE SHEATH, THE BALLOON DEFLATED IMMEDIATELY. REPORTEDLY, THE PATIENT HAD SEVERE ILIAC TORTUOSITY. THROMBECTOMY WAS SUCCESSFUL AND THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12668740 ↗

Other Catheter, Percutaneous, Neurovasculature devices

All Catheter, Percutaneous, Neurovasculature devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.