Mini Ghost™ 612542Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964341243), received between Nov 11, 2019 and Nov 11, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryNov 11, 2019Break; Melted; Material Rupture

  AS PER THE REPORT FROM THE DISTRIBUTOR / HOSPITAL - WE WENT UP TO 30 ATM AND IT JUST BROKE. WE GOT HALF OF THE BALLOON OUT AND THEN CONTINUED TO PULL OUT PIECES AFTER. THE SURGEON GOT THE BIGGER PIECE OUT OF THE SUBCLAVIAN. IT LOOKED LIKE IT HAD MELTED ONTO THE GUIDEWIRE. THE BALLOON RUPTURED BOTH CIRCUMFERENTIALLY AND LONGITUDINALLY. THE PHYSICIAN WAS USING THE BALLOON FOR ANGIOPLASTY RIGHT PULMONARY ARTERY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED - MERIT GAUGE BASIC COMPACT INFLATION SYRINGE - 30ATM. THE SIZE AND TYPE OF INTRODUCER SHEATH USED WAS A 4F 45 CHB PERFORMER SHEATH; THE COOK ABBOT WORKHORSE .018 X 200 FLEX T GUIDEWIRE WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THE PATIENT HAS A CONGENITAL DEFECT - TETRALOGY OF FALLOT. THE PATIENT CONDITION POST PROCEDURE WAS STABLE. A SECOND BALLOON WAS NOT USED TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9304814 ↗