Pantera LEO 3.5/8/145Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130415553), received between Aug 13, 2019 and Aug 19, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 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.

• MalfunctionAug 19, 2021Material Rupture; Material Rupture

  AFTER PRE-DILATATION OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MID RCA WITH A SEMI-COMPLIANT BALLOON, A STENT WAS DEPLOYED. SINCE THE STENT WAS INSUFFICIENTLY EXPANDED, THE PANTERA LEO WAS SELECTED FOR POST-DILATATION BUT RUPTURED DURING INFLATION AT 20 ATM. THE DEVICE WAS RETRIEVED. SUBSEQUENTLY, ANOTHER NON-COMPLIANT BALLOON WAS USED FOR ADDITIONAL POST-DILATATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342388 ↗
• MalfunctionJun 10, 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. ORIGINALLY REPORTED ON MDR-1028232-2021-00879, UNDER INCORRECT LOT NUMBER. CLOSED THAT REPORT AS BEING OPENED IN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978100 ↗
• MalfunctionMar 31, 2021Material Rupture; Material Rupture

  A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE RCA. THE BALLOON RUPTURED DURING INFLATION AT 18 ATM. ANOTHER BALLOON CATHETER WAS USED FOR THE INTERVENTION. IT WAS STATED THAT IT OCCURRED DUE TO CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595549 ↗
• 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 11350890 ↗
• MalfunctionOct 23, 2019Material Rupture; Material Rupture

  THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR USE IN THE RCA. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225325 ↗
• MalfunctionAug 13, 2019Failure to Advance; Failure to Advance

  A PANTERA LEO BALLOON WAS CHOSEN TO TREAT A SEVERE CALCIFIED LESION (83 PERCENT STENOSIS DEGREE) IN A SEVERE TORTUOUS LAD. DESPITE REPEATED ATTEMPTS IT WAS NOT POSSIBLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889861 ↗