Pantera Pro 2.00/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130437043), received between May 9, 2019 and Dec 30, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  THE PANTERA PRO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE PROXIMAL LCX. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY, BUT ONCE POSITIONED INSIDE THE TARGET LESION THE BALLOON COULD NOT BE INFLATED. THE AFFECTED DEVICE WAS WITHDRAWN AND WAS SCRAPPED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044962 ↗
• MalfunctionMar 20, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AFTER A PRE-DILATATION OF THE MID LAD AND DIAGONAL 2 AND SUCCESSFUL STENT PLACEMENT IN THE MID LAD, A 2.0/15 PANTERA PRO CORONARY BALLOON CATHETER (COMPLAINT DEVICE) WAS SELECTED FOR A POST-DILATION IN THE DIAGONAL 2, BUT THE LESION COULD NOT BE CROSSED. THEREFORE, ANOTHER 1.5/10 PANTERA PRO WAS TRIED. AGAIN, THE LESION COULD NOT BE CROSSED WITH THE DEVICE (REPORTED SEPARATELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18946531 ↗
• MalfunctionJan 4, 2023Failure to Advance; Failure to Advance

  A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN TO SQUEEZE THE PLAQUE INTO THE VESSEL WALL OF THE PROXIMAL LAD, BUT THE BALLOON CATHETER COULD NOT PASS THROUGH THE SEVERELY CALCIFIED LESION WITH 94 PERCENT STENOSIS DEGREE. ANOTHER PANTERA PRO WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096179 ↗
• 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 (70 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 16019797 ↗
• MalfunctionMay 9, 2019Fracture; Fracture

  OUS MDR - WHILE CONNECTING THE INDEFLATOR TO THE HUB OF THE PANTERA PRO BALLOON CATHETER A HUB FRACTURE WAS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595440 ↗