Pantera ProRecalls & reported problems across all models
Biotronik AG · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 13 models of Pantera Pro by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2019 and Aug 20, 2025 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (11 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 Pro problems
Device problems
- Failure to Advance11
- Material Deformation6
- Inflation Problem5
- Fracture4
- Material Rupture2
- Difficult to Remove1
- Fluid/Blood Leak1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient6
- Vascular Dissection1
Pantera Pro models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pantera Pro 2.00/15/140Catheters, transluminal coronary angioplasty, percutaneous5 reports
- Pantera Pro 2.50/20/140Catheters, transluminal coronary angioplasty, percutaneous4 reports
- Pantera Pro 2.00/10/140Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera Pro 2.50/15/140Catheters, transluminal coronary angioplasty, percutaneous3 reports
- Pantera Pro 1.25/10/140Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Pantera Pro 1.50/15/140Catheters, transluminal coronary angioplasty, percutaneous2 reports
- Pantera Pro 1.50/10/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 2.50/10/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 1.25/15/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 3.00/15/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 3.50/15/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 1.25/20/140Catheters, transluminal coronary angioplasty, percutaneous1 report
- Pantera Pro 2.00/20/140Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent Pantera Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Inflation Problem; Material Deformation; Inflation Problem; Material Deformation
THE PANTERA PRO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE LAD. IT WAS REPORTED THAT THE BALLOON WAS KINKED IN THE PACKAGING AND WOULD NOT INFLATE. IT WAS NOT POSSIBLE TO APPLY ANY PRESSURE TO THE BALLOON. NO CONTRAST PASSED THROUGH THE INFLATION DEVICE TO THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847385 ↗MalfunctionApr 22, 2025Inflation Problem; Inflation Problem
THE PANTERA PRO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON DID NOT DEPLOY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881839 ↗MalfunctionDec 30, 2024Inflation Problem; Material Deformation; Inflation Problem; Material Deformation
THE PANTERA PRO CORONARY BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE PROXIMAL LCX. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY, BUT ONCE POSITIONED INSIDE THE TARGET LESION THE BALLOON COULD NOT BE INFLATED. THE AFFECTED DEVICE WAS WITHDRAWN AND WAS SCRAPPED AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21044962 ↗MalfunctionMar 20, 2024Failure to Advance; Failure to Advance
AFTER A PRE-DILATATION OF THE MID LAD AND DIAGONAL 2 AND SUCCESSFUL STENT PLACEMENT IN THE MID LAD, A 2.0/15 PANTERA PRO CORONARY BALLOON CATHETER WAS SELECTED FOR A POST-DILATION IN THE DIAGONAL 2, BUT THE LESION COULD NOT BE CROSSED WITH THE DEVICE (REPORTED SEPARATELY). THEREFORE, ANOTHER 1.5/10 PANTERA PRO (COMPLAINT DEVICE) WAS TRIED. AGAIN, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946555 ↗MalfunctionMar 20, 2024Failure to Advance; Failure to Advance
AFTER PRE-DILATATION OF THE LESION WITH A PANTERA BALLOON 3.0/15, AN UNKNOWN STENT WAS INSERTED IN THE MID LAD. SUBSEQUENTLY, THE COMPLAINT PANTERA PRO WAS ATTEMPTED TO BE USED FOR PRE-DILATATION IN A SIDE BRANCH OF THE LAD, BUT THE BALLOON DID NOT PASS. A 2ND ATTEMPT WAS MADE BUT THE BALLOON STILL DID NOT CROSS THE SIDE BRANCH. IT WAS DECIDED TO STOP THE PROCEDURE, CONTINUE TO GIVE MEDICINE TO PATIENT, AND MADE APPOINTMENT FOR A FOLLOW UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946544 ↗MalfunctionMar 20, 2024Failure to Advance; Failure to Advance
AN UNKNOWN STENT WAS INSERTED IN THE LAD. SUBSEQUENTLY, THE COMPLAINT PANTERA PRO WAS ATTEMPTED TO BE USED FOR PRE-DILATATION IN THE LCX, BUT THE BALLOON DID NOT PASS. A 2ND ATTEMPT WAS MADE BUT THE BALLOON STILL DID NOT CROSS THE SIDE BRANCH. IT WAS DECIDED NOT TO DO THE POBA PROCEDURE YET, CONTINUED TO GIVE MEDICINE TO PATIENT AND MADE AN APPOINTMENT FOR A FOLLOW UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946535 ↗MalfunctionMar 20, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
AFTER A PRE-DILATATION OF THE MID LAD AND DIAGONAL 2 AND SUCCESSFUL STENT PLACEMENT IN THE MID LAD, A 2.0/15 PANTERA PRO CORONARY BALLOON CATHETER (COMPLAINT DEVICE) WAS SELECTED FOR A POST-DILATION IN THE DIAGONAL 2, BUT THE LESION COULD NOT BE CROSSED. THEREFORE, ANOTHER 1.5/10 PANTERA PRO WAS TRIED. AGAIN, THE LESION COULD NOT BE CROSSED WITH THE DEVICE (REPORTED SEPARATELY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18946531 ↗MalfunctionJul 20, 2023Fracture; Fracture
THE PHYSICIAN INTENDED TO TREAT A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF AN UNSPECIFIED ABDOMINAL VESSEL. THE USED ACCESSORIES WERE A 4F AND A 6F FORTRESS INTRODUCER SHEATH AND TWO GUIDEWIRES (1X 0.014 INCH COMMAND HI TORQUE AND 1X 0.014 INCH GLIDEWIRE ADVANCE). THE ONLY INFORMATION AVAILABLE IS THAT DURING WITHDRAWAL THE COMPLAINT INSTRUMENT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17363837 ↗MalfunctionJun 20, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THE PANTERA PRO COMPLIANT BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 95 PERCENT STENOSIS DEGREE. WHEN PUSHING THE BALLOON CATHETER TO THE LESION SITE, THE PROXIMAL END OF THE CATHETER WAS BENT. THE DEVICE COULD NOT PASS THROUGH THE CALCIFIED LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163799 ↗InjuryMay 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 17004042 ↗MalfunctionJan 4, 2023Failure to Advance; Failure to Advance
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN TO SQUEEZE THE PLAQUE INTO THE VESSEL WALL OF THE PROXIMAL LAD, BUT THE BALLOON CATHETER COULD NOT PASS THROUGH THE SEVERELY CALCIFIED LESION WITH 94 PERCENT STENOSIS DEGREE. ANOTHER PANTERA PRO WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096179 ↗MalfunctionDec 20, 2022Failure to Advance; Failure to Advance
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS DISTAL LAD. THE DEVICE IS UNABLE TO CROSS THE PRE-DILATED LESION. THE DEVICE WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16019797 ↗MalfunctionDec 20, 2022Failure to Advance; Failure to Advance
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS DISTAL LAD. THE DEVICE IS UNABLE TO CROSS THE PRE-DILATED LESION. THE DEVICE WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16019792 ↗MalfunctionNov 29, 2022Material Puncture/Hole; Material Puncture/Hole
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE IN THE PROXIMAL LAD. AT THE TIME OF PRE-DILATION, THE BALLOON DID NOT INFLATE, IT WAS REMOVED AND OBSERVED TO BE PUNCTURED. A NEW BALLOON WAS USED FOR PRE-DILATION WITHOUT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15880754 ↗MalfunctionAug 8, 2022Fracture; Fracture
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL RCA. WHEN REMOVING THE TRANSPORTATION WIRE, THE BALLOON WAS STUCK TO THE WIRE AND TORE OFF THE DELIVERY SYSTEM. IT WAS NOT RECOGNIZED, AND THE DEVICE WAS INTRODUCED INTO THE GUIDING CATHETER. BECAUSE THE BALLOON WAS NOT SEEN IN THE IMAGING THE DEVICE WAS REMOVED. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION. UDI (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15188171 ↗
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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