Pantera LEO 3.5/12/145Recalls & reported problems
Biotronik AG · Class 2
All models of Pantera LEO (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130415669), received between Jul 18, 2019 and Mar 25, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (6 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
Device problems
- Material Rupture6
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2021Material Rupture; Material Rupture
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LAD. THE PANTERA LEO WAS INFLATED UP TO NP TWICE. DURING THE SECOND INFLATION THE BALLOON RUPTURED. THE PANTERA LEO WAS REMOVED TOGETHER WITH THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11568870 ↗MalfunctionJul 1, 2020Material Rupture; Material Rupture
A PANTERA LEO CORONARY BALLOON SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION. THE BALLOON RUPTURED AT 12 ATM DURING INFLATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10219931 ↗MalfunctionJun 26, 2020Material Rupture; Material Rupture
A PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS VESSEL. DURING INFLATION UP TO 14 ATM THE BALLOON RUPTURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10202595 ↗MalfunctionMar 26, 2020Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION IN THE LAD. DURING INFLATION THE BALLOON RUPTURED AT 17 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9885322 ↗MalfunctionFeb 6, 2020Material Rupture; Material Rupture
A PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION. DURING INFLATION THE BALLOON RUPTURED AT 18 ATM. THUS ANOTHER BALLOON WAS USED FOR THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9677856 ↗MalfunctionJul 18, 2019Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR USE. DURING INFLATION THE BALLOON RUPTURED AT 16 BAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8802300 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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