Pantera LEO 2.5/12/145Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130415621), received between May 19, 2019 and Mar 22, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (93 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID LAD. PRESSURE WAS APPLIED (20 ATM) BUT THE BALLOON DID NOT INFLATE PROPERLY. CONTRAST MEDIUM LEAKED FROM BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544570 ↗
• MalfunctionJan 6, 2021Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS USED FOR THE POST-DILATATION OF ANOTHER STENT. AT FIRST THE PANTERA LEO WAS INFLATED AT THE STENT MIDDLE WITH 15 ATM. DURING THE SECOND INFLATION AT THE PROXIMAL SIDE OF THE STENT THE PANTERA LEO BALLOON RUPTURED AT 15 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125749 ↗
• MalfunctionSep 25, 2020Activation Failure; Activation Failure

  THE PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE LAD. AFTER PREPARATION OF THE LESION WITH A CUTTING BALLOON THE DEVICE WAS INSERTED BUT IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THUS, THE DEVICE WAS REMOVED FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10589645 ↗
• MalfunctionNov 6, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS LAD. THE BALLOON WAS INFLATED UP TO 20 ATM BUT IT DID NOT INFLATE CORRECTLY. IT WAS DETECTED THAT CONTRAST MEDIUM WAS LEAKING OUT THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9288259 ↗
• MalfunctionSep 10, 2019Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR USE. DURING THE SECOND PREDILATATION, THE BALLOON RUPTURED AT 20 BAR. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER BALLOON CATHETER WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982329 ↗
• MalfunctionJul 2, 2019Material Rupture; Material Rupture

  DURING INFLATION THE PANTERA LEO 2.5/12 BALLOON CATHETER RUPTURED. NO MORE INFORMATION AVAILABLE SO FAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755453 ↗
• MalfunctionJun 28, 2019Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS USED FOR PRE-DILATATION BUT THE BALLOON RUPTURED DURING INFLATION AT 20 BAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746031 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  A PANTERA LEO WAS CHOSEN TO TREAT A SEVERLY CALCIFIED LESION (93% STENOSIS DEGREE) IN A MID LAD. DESPITE REPEATED ATTEMPTS THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712216 ↗
• MalfunctionMay 19, 2019Material Rupture; Material Rupture

  A PANTERA LEO BALLOON CATHETER WAS SELECTED TO TREAT A SEVERE CALCIFIED LESION (98% STENOSIS DEGREE) IN A TORTUOUS RCA. THE BALLOON BURST AT 20 ATM (RBP) DURING INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8622528 ↗