Pantera LEO 2.75/12/145Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130415638), received between May 14, 2018 and Jun 3, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2024Failure to Advance; Failure to Advance
THE PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A LESION WITH A 99 PERCENT OCCLUSIVE THROMBUS AT PROXIMAL TO MID RCA. IT WAS ATTEMPTED TO ADVANCE THE DEVICE, BUT THE LESION COULD NOT BE CROSSED. THE PANTERA LEO WAS REMOVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19449731 ↗MalfunctionMay 20, 2020Material Rupture; Material Rupture
A PANTERA LEO BALLOON SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE LAD. AFTER TWO INFLATIONS UP TO 16 ATM, THE BALLOON RUPTURED AT 14 ATM DURING THIRD INFLATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10077265 ↗MalfunctionMay 14, 2018Failure to Advance; Failure to Advance
OUS MDR - THE DEVICE COULD NOT PASS THE SEVERELY CALCIFIED LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7511229 ↗
Other Catheters, transluminal coronary angioplasty, percutaneous devices
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- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- 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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