Pantera LEO 3.0/12/145Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130415645), received between Apr 23, 2019 and May 13, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (4 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 Rupture4
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture
A PANTERA LEO BALLOON SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (98 PERCENT STENOSIS DEGREE) IN THE LAD. DURING INFLATION THE BALLOON BURST AT 14 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10051167 ↗MalfunctionApr 2, 2020Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A CALCIFIED LESION IN THE LAD. DURING THE SECOND INFLATION THE BALLOON RUPTURED AT TWENTY ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9915511 ↗MalfunctionSep 10, 2019Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION. DURING THE THIRD INFLATION, 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 8982316 ↗MalfunctionApr 23, 2019Material Rupture; Material Rupture
OUS MDR - THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540414 ↗
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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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