Pantera LEO 2.5/15/145Recalls & 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
- 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 07640130415737), received between Jun 18, 2019 and Oct 26, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Material Rupture1
- Use of Device Problem1
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.
MalfunctionOct 26, 2020Use of Device Problem; Use of Device Problem
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. WHEN REMOVING THE BALLOON PROTECTOR, THE TRANSPORTATION WIRE/STYLET WAS FOUND KINKED AND PUNCTURED THE PHYSICIANS GLOVE, WHICH CAUSE BLEEDING ON PHYSICIANS FINGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10737627 ↗MalfunctionSep 11, 2019Fracture; Fracture
A PANTERA LEO BALLOON CATHETER WAS CHOSEN FOR TREADING A SEVERELY CALCIFIED LESION IN THE LAD BY RETROGRADE APPROACH THROUGH A BYPASS GRAFT. WHEN THE INSTRUMENT WAS WITHDRAWN AFTER INFLATION IT WAS NOTICED THAT THE SHAFT BROKE AT ITS DISTAL END. THE FRACTURED PART REMAINED INSIDE THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8992380 ↗MalfunctionJun 18, 2019Material Rupture; Material Rupture
A PANTERA LEO WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A TORTUOUS RCA. DURING SECOND INFLATION AT 14 ATM THE BALLOON RUPTURED AFTER 10 SECONDS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8707874 ↗
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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 13, 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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