Pantera LEO 3.0/15/145Recalls & reported problems
Biotronik AG · Class 2
All models of Pantera LEO (30)
Data updated Oct 16, 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 07640130415751), received between Apr 23, 2019 and Aug 3, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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 16, 2026.
Most reported problems
Device problems
- Material Rupture2
- Failure to Advance1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Failure to Advance; Failure to Advance
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID LAD. IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE PANTERA LEO BALLOON CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12271389 ↗MalfunctionMar 26, 2020Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A SEVERELY CALCIFIED LESION IN THE LAD. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9886104 ↗MalfunctionDec 2, 2019Material Rupture; Material Rupture
THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR DILATATION. DURING INFLATION THE BALLOON RUPTURED AT 14 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9396547 ↗MalfunctionApr 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
OUS MDR - THE PANTERA LEO BALLOON CATHETER WAS SELECTED FOR POST-DILATATION. DURING INFLATION UP TO 18 ATM AND 22 ATM A LEAKAGE WAS NOTICED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8540411 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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