Pantera Pro 2.00/10/140Recalls & reported problems
Biotronik AG · Class 2
All models of Pantera Pro (13)
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 07640130436978), received between Jul 23, 2020 and Mar 20, 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
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 8, 2020Failure to Advance; Failure to Advance
A PANTERA PRO BALLOON SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE DISTAL LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10652830 ↗MalfunctionJul 23, 2020Inflation Problem; Inflation Problem
A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON COULD NOT BE INFLATED. ANOTHER DEVICE WAS USED TO FINISH THE TREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10315771 ↗
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- 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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