Pantera LEO 3.5/15/145Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130415775), received between Aug 6, 2019 and May 25, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS INTENDED TO TREAT A MILDLY CALCIFIED ECCENTRIC TYPE B1 LESION (95 PERCENT STENOSIS DEGREE,) IN A SEGMENT OF THE RCA. THE LESION WAS PRE-DILATED WITH THE PANTERA PRO 2.5/20 COMPLIANT BALLOON CATHETER ONCE, FOLLOWED BY A PANTERA LEO 3.5/15 NC BALLOON CATHETER, WHICH WAS INFLATED TWICE. AFTER THIS PRE-DILATATION, A LOCALIZED DISSECTION WAS NOTED IN THE TREATED AREA. SUBSEQUENTLY, A SCAFFOLD WAS IMPLANTED AND POST-DILATATION WAS DONE. THEREBY THE DISSECTION WAS FIXED. BOTH BALLOON CATHETERS ARE REPORTED SEPARATELY.

  Patient problems: Vascular Dissection

  MAUDE report 17004053 ↗
• MalfunctionMay 4, 2021Flaked; Flaked

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. AFTER WITHDRAWAL OF THE DEVICE IT WAS OBSERVED THAT THE HYPOTUBE OF THE CATHETER WAS FRAYED AT ABOUT 25 CM FROM GUIDE WIRE EXIT PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770513 ↗
• MalfunctionFeb 19, 2021Difficult to Remove; Difficult to Remove

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. DIFFICULTIES WERE EXPERIENCED IN WITHDRAWING THE PANTERA LEO OVER A GUIDE WIRE. BOTH DEVICES HAD TO BE REMOVED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350936 ↗
• MalfunctionDec 9, 2020Material Rupture; Material Rupture

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR POST-DILATATION OF A STENT IN THE LAD. DURING THE THIRD INFLATION AT 16 ATM, A LEAKAGE WAS NOTED AND IT WAS CONFIRMED THE BALLOON HAS BEEN RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978991 ↗
• MalfunctionNov 6, 2019Fracture; Fracture

  A PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREADING A CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE RCA. AFTER SUCCESSFUL TREATMENT, DURING WITHDRAWAL THE DEVICE FRACTURED. THE DISTAL PART COULD BE REMOVED WITH A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288255 ↗
• MalfunctionAug 6, 2019Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A TORTUOUS LEFT CORONARY VESSEL. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866662 ↗