Pantera LEORecalls & reported problems across all models
Biotronik AG · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 30 models of Pantera LEO by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between May 14, 2018 and May 19, 2026 — classified as 2 injuries, 76 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Pantera LEO problems
Device problems
- Material Rupture41
- Failure to Advance13
- Fluid/Blood Leak4
- Fracture4
- Inflation Problem4
- Leak/Splash4
- Difficult to Remove3
- Activation Failure1
Patient problems
- No Consequences Or Impact To Patient45
- No Clinical Signs, Symptoms or Conditions27
- Vascular Dissection2
- Hematoma1
- Insufficient Information1
- Myocardial Infarction1
- No Information1
- No Known Impact Or Consequence To Patient1
Pantera LEO models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pantera LEO 2.5/12/145Catheters, transluminal coronary angioplasty, percutaneous9 reports
- Pantera LEO 3.5/8/145Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Pantera LEO 3.5/12/145Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Pantera LEO 4.0/12/145Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Pantera LEO 3.5/15/145Catheters, transluminal coronary angioplasty, percutaneous6 reports
- Pantera LEO 4.0/8/145Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Pantera LEO 3.0/12/145Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Pantera LEO 3.0/15/145Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Pantera LEO 3.0/8/145Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera LEO 2.75/12/145Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera LEO 2.5/15/145Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera LEO 3.75/15/145Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera LEO 2.5/8/145Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Pantera LEO 2.0/12/145Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Pantera LEO 2.25/8/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 2.75/8/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.25/8/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.75/8/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.25/12/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 5.0/12/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 2.75/15/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.25/15/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 4.0/15/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 2.25/20/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 2.5/20/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.5/20/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.75/20/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 2.5/30/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 3.0/30/145Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera LEO 4.0/30/145Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Pantera LEO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Failure to Deflate
THE PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. BALLOON COULD NOT BE DEFLATED. A HOLE WAS DETECTED. ANOTHER BALLOON WAS USED.
Patient problems: Insufficient Information
MAUDE report 25213576 ↗MalfunctionFeb 21, 2025Inflation Problem; Inflation Problem
THE PANTERA LEO CORONARY BALLOON CATHETER WAS INSERTED TO POST-DILATE A STENT IN A MODERATELY TORTUOUS PART OF THE PROXIMAL CX. WHEN INFLATED UP TO 18 BAR NO CONTRAST WAS VISIBLE IN THE BALLOON. IT WAS NOT POSSIBLE TO POST-DILATE OPTIMALLY WITHOUT VISUAL CONFIRMATION. ANOTHER NC BALLOON WAS USED FOR POST-DILATATION OF THE IMPLANTED STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434704 ↗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 21, 2024Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (STENOSIS DEGREE: 96 PERCENT). AFTER RELEASING A STENT, IT WAS OBSERVED, THAT THE STENT DID NOT EXPAND. THEREFORE, A PANTERA LEO BALLOON WAS USED. THE BALLOON WAS INSERTED AND INFLATED UNTIL 8 AMT, BUT THE BALLOON BURST. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359948 ↗InjurySep 19, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING THE PROCEDURE, A 4.0/12 PANTERA LEO NC BALLOON WAS REQUESTED AND WAS GIVEN A 4.0/12 BOX FROM THE SHELF. THE INNER BAG WAS OPENED, AND THE BALLOON WAS HANDED OVER TO THE PHYSICIAN. ON USE, PATIENT CONSEQUENCE: STENT HEMATOMA AND DISSECTION (CONFIRMED IN IVUS) AS WELL AS STENT OVEREXPANSION. PATIENT WAS STABLE AT END OF PROCEDURE. AFTER CHECKING WHEN WRITING UP THE REPORT, IT WAS DETECTED THAT AN NC 4.5 BALLOON HAD BEEN SCANNED IN THE LIST OF MATERIALS, WHEREAS HE HAD REQUESTED A 4.0. AFTER THE TEAM CHECKED THE PACKAGING IN THE GARBAGE CAN, THE BALLOONS INNER PACKAGING WAS A 4.5/12 AND NOT A 4.0 AS INDICATED ON THE OUTER CARDBOARD BOX.
Patient problems: Hematoma; Vascular Dissection
MAUDE report 17777660 ↗MalfunctionMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS INTENDED TO TREAT A MILDLY CALCIFIED ECCENTRIC TYPE B1 LESION (95 PERCENT STENOSIS DEGREE,) IN A SEGMENT OF THE RCA. THE LESION WAS PRE-DILATED WITH THE PANTERA PRO 2.5/20 COMPLIANT BALLOON CATHETER ONCE, FOLLOWED BY A PANTERA LEO 3.5/15 NC BALLOON CATHETER, WHICH WAS INFLATED TWICE. AFTER THIS PRE-DILATATION, A LOCALIZED DISSECTION WAS NOTED IN THE TREATED AREA. SUBSEQUENTLY, A SCAFFOLD WAS IMPLANTED AND POST-DILATATION WAS DONE. THEREBY THE DISSECTION WAS FIXED. BOTH BALLOON CATHETERS ARE REPORTED SEPARATELY.
Patient problems: Vascular Dissection
MAUDE report 17004053 ↗InjuryApr 20, 2023Fracture; Fracture
THE PANTERA LEO CORONARY BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 80-90 PERCENT STENOSIS DEGREE IN THE MILDLY TORTUOUS OM. AFTER REACHING RBP, THE BALLOON RUPTURED. IT WAS TRIED TO REMOVE THE BALLOON, BUT THE MARKERS STAYED IN PLACE. IT WAS TRIED TO GET A WIRE DOWN TO STENT THE BALLOON BUT ABANDONED IT, DUE TO PATIENT DECLINING AND NOT BEING SUCCESSFUL. EVENTUALLY, RADIOGRAPHY SHOWED THE BALLOON DOWN IN THE OM VESSEL.
Patient problems: Myocardial Infarction
MAUDE report 16779261 ↗MalfunctionJul 12, 2022Failure to Advance; Failure to Advance
THE LESION WAS A HIGHLY CALCIFIED LESION WITHIN THE LAD AND THE PROCEDURE WAS PLANNED FOR ROTA ABLATION. AFTER SION BLUE (GW) PASSED THROUGH THE LESION, IT WAS TRIED TO DELIVER THE PANTERA LEO. HOWEVER, THE BALLOON DID NOT PASS THROUGH THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14986768 ↗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 ↗MalfunctionFeb 7, 2022Inflation Problem; Inflation Problem
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD. THE BALLOON DID NOT INFLATE AT ALL WHEN FIRST INFLATED. THEREFORE, THIS DEVICE WAS REMOVED FROM THE PATIENT, AND ANOTHER PANTERA LEO WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13471106 ↗MalfunctionAug 19, 2021Material Rupture; Material Rupture
AFTER PRE-DILATATION OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MID RCA WITH A SEMI-COMPLIANT BALLOON, A STENT WAS DEPLOYED. SINCE THE STENT WAS INSUFFICIENTLY EXPANDED, THE PANTERA LEO WAS SELECTED FOR POST-DILATATION BUT RUPTURED DURING INFLATION AT 20 ATM. THE DEVICE WAS RETRIEVED. SUBSEQUENTLY, ANOTHER NON-COMPLIANT BALLOON WAS USED FOR ADDITIONAL POST-DILATATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342388 ↗MalfunctionAug 10, 2021Material Rupture; Material Rupture
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A LESION (99 PERCENT STENOSIS DEGREE IN THE RCA. THE DEVICE WAS ADVANCED TO THE LESION AND INFLATED, BUT RUPTURED AT 18 ATM. ANOTHER BALLOON WITH SAME SIZE WAS USED AFTERWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305020 ↗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 ↗MalfunctionJun 10, 2021Difficult to Remove; Difficult to Remove
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. DIFFICULTIES WERE EXPERIENCED IN WITHDRAWING THE PANTERA LEO OVER A GUIDE WIRE. BOTH DEVICES HAD TO BE REMOVED TOGETHER. ORIGINALLY REPORTED ON MDR-1028232-2021-00879, UNDER INCORRECT LOT NUMBER. CLOSED THAT REPORT AS BEING OPENED IN ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11978100 ↗MalfunctionMay 4, 2021Flaked; Flaked
A PANTERA LEO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. AFTER WITHDRAWAL OF THE DEVICE IT WAS OBSERVED THAT THE HYPOTUBE OF THE CATHETER WAS FRAYED AT ABOUT 25 CM FROM GUIDE WIRE EXIT PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770513 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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