Pantera LEO 4.0/8/145Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130415577), received between Aug 15, 2019 and May 18, 2022 — classified as 5 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
Device problems
- Material Rupture3
- Failure to Advance1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2022Failure to Advance; Failure to Advance
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MILDLY TORTUOUS LAD. THE DEVICE COULD NOT PASS THE LESION AND WAS WITHDRAWN. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14431474 ↗MalfunctionApr 10, 2020Material Rupture; Material Rupture
THREE PANTERA LEO BALLOON CATHETERS WERE SELECTED FOR PRE-DILATATION OF A CALCIFIED LESION DURING THE SAME INTERVENTION (20032003, 20032004 & 20032005). DURING INFLATION THE THREE BALLOONS RUPTURED AT 14 TO 16 BAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9949270 ↗MalfunctionApr 10, 2020Material Rupture; Material Rupture
THREE PANTERA LEO BALLOON CATHETERS WERE SELECTED FOR PRE-DILATATION OF A CALCIFIED LESION DURING THE SAME INTERVENTION (20032003, 20032004 & 20032005). DURING INFLATION THE THREE BALLOONS RUPTURED AT 14 TO 16 BAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9949266 ↗MalfunctionApr 10, 2020Material Rupture; Material Rupture
THREE PANTERA LEO BALLOON CATHETERS WERE SELECTED FOR PRE-DILATATION OF A CALCIFIED LESION DURING THE SAME INTERVENTION (20032003, 20032004 & 20032005). DURING INFLATION THE THREE BALLOONS RUPTURED AT 14 TO 16 BAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9949259 ↗MalfunctionAug 15, 2019Inflation Problem; Inflation Problem
THE PANTERA LEO BALLOON CATHETER WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION IN THE MEDIAL LAD. DURING THE PROCEDURE IT WAS NOT POSSIBLE TO INFLATE THE BALLOON AT ALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897185 ↗
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- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
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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