Pantera Pro 2.50/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130437050), received between Mar 20, 2019 and Dec 20, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Failure to Advance; Failure to Advance

  A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS DISTAL LAD. THE DEVICE IS UNABLE TO CROSS THE PRE-DILATED LESION. THE DEVICE WAS WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019792 ↗
• MalfunctionNov 29, 2022Material Puncture/Hole; Material Puncture/Hole

  A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE IN THE PROXIMAL LAD. AT THE TIME OF PRE-DILATION, THE BALLOON DID NOT INFLATE, IT WAS REMOVED AND OBSERVED TO BE PUNCTURED. A NEW BALLOON WAS USED FOR PRE-DILATION WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880754 ↗
• MalfunctionMar 20, 2019Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS INTENDED TO TREAT A CALCIFIED LESION (70% STENOSIS DEGREE) IN A TORTUOUS LAD. THE BALLOON COULD NOT BE INFLATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438483 ↗