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Mini Ghost™ 612551Recalls & reported problems

B Braun Interventional Systems, Inc · MG150 MINI GHOST BALLOON 6 X 2 X 80 · 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 04046964341427), received between Sep 20, 2018 and Sep 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

  • Burst Container or Vessel1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionSep 20, 2018Burst Container or Vessel

    AS REPORTED BY THE DISTRIBUTOR BIS AND THE HOSPITAL: "THE BALLOON BURST. IT IS UNKNOWN WHETHER AN INFLATION DEVICE WAS USED." UPDATED 9/18/2018 - " WE BALLOONED THE INNOMINATE VEIN IN STENT RESTENOSIS WITH THE MINI GHOST TO 24 ATMS, WHICH WAS USED 1 TIME BEFORE TO INFLATE THE BALLOON. THE SHEATH WAS A 6FR MULLINS SHEATH AND IT WAS NOT KINKED. THE PATIENT HAD CONGENITAL ANOMALIES. AFTER USING THE MINI GHOST, WE USED 6FR AND 7FR 75 MUSTANGS. THE BALLOON BURST AT 24ATMS."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7893140 ↗

Other CATHETER, PERCUTANEOUS devices

All CATHETER, PERCUTANEOUS devices →

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