Pantera Pro 1.50/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130437036), received between Aug 8, 2022 and Jun 20, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PANTERA PRO COMPLIANT BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 95 PERCENT STENOSIS DEGREE. WHEN PUSHING THE BALLOON CATHETER TO THE LESION SITE, THE PROXIMAL END OF THE CATHETER WAS BENT. THE DEVICE COULD NOT PASS THROUGH THE CALCIFIED LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163799 ↗
• MalfunctionAug 8, 2022Fracture; Fracture

  A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL RCA. WHEN REMOVING THE TRANSPORTATION WIRE, THE BALLOON WAS STUCK TO THE WIRE AND TORE OFF THE DELIVERY SYSTEM. IT WAS NOT RECOGNIZED, AND THE DEVICE WAS INTRODUCED INTO THE GUIDING CATHETER. BECAUSE THE BALLOON WAS NOT SEEN IN THE IMAGING THE DEVICE WAS REMOVED. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION. UDI (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188171 ↗