Pantera LEO 4.0/12/145Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130415683), received between May 9, 2019 and Feb 21, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 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.

• MalfunctionFeb 21, 2025Inflation Problem; Inflation Problem

  THE PANTERA LEO CORONARY BALLOON CATHETER WAS INSERTED TO POST-DILATE A STENT IN A MODERATELY TORTUOUS PART OF THE PROXIMAL CX. WHEN INFLATED UP TO 18 BAR NO CONTRAST WAS VISIBLE IN THE BALLOON. IT WAS NOT POSSIBLE TO POST-DILATE OPTIMALLY WITHOUT VISUAL CONFIRMATION. ANOTHER NC BALLOON WAS USED FOR POST-DILATATION OF THE IMPLANTED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434704 ↗
• InjurySep 19, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE PROCEDURE, A 4.0/12 PANTERA LEO NC BALLOON WAS REQUESTED AND WAS GIVEN A 4.0/12 BOX FROM THE SHELF. THE INNER BAG WAS OPENED, AND THE BALLOON WAS HANDED OVER TO THE PHYSICIAN. ON USE, PATIENT CONSEQUENCE: STENT HEMATOMA AND DISSECTION (CONFIRMED IN IVUS) AS WELL AS STENT OVEREXPANSION. PATIENT WAS STABLE AT END OF PROCEDURE. AFTER CHECKING WHEN WRITING UP THE REPORT, IT WAS DETECTED THAT AN NC 4.5 BALLOON HAD BEEN SCANNED IN THE LIST OF MATERIALS, WHEREAS HE HAD REQUESTED A 4.0. AFTER THE TEAM CHECKED THE PACKAGING IN THE GARBAGE CAN, THE BALLOONS INNER PACKAGING WAS A 4.5/12 AND NOT A 4.0 AS INDICATED ON THE OUTER CARDBOARD BOX.

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 17777660 ↗
• MalfunctionJul 12, 2022Failure to Advance; Failure to Advance

  THE LESION WAS A HIGHLY CALCIFIED LESION WITHIN THE LAD AND THE PROCEDURE WAS PLANNED FOR ROTA ABLATION. AFTER SION BLUE (GW) PASSED THROUGH THE LESION, IT WAS TRIED TO DELIVER THE PANTERA LEO. HOWEVER, THE BALLOON DID NOT PASS THROUGH THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986768 ↗
• MalfunctionDec 1, 2020Failure to Advance; Failure to Advance

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS MID LAD. THE DEVICE COULD NOT CROSS THE LESION. ANOTHER BALLOON WITH SAME SIZE WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929544 ↗
• MalfunctionSep 29, 2020Material Rupture; Material Rupture

  A PANTERA LEO BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE RCA. DURING INFLATION THE BALLOON RUPTURED AT 16 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10601334 ↗
• MalfunctionMay 9, 2019Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR POST-DILATATION. DURING THE ATTEMPT TO INFLATE IT FOR THE SECOND TIME THE BALLOON RUPTURED AT 20 ATM. THEREFORE IT WAS REPLACED AND THE PROCEDURE WAS FINISHED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595436 ↗