Pantera Pro 2.50/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130437128), received between Jul 1, 2019 and Mar 20, 2024 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 13, 2021Fracture; Fracture

  A PANTERA PRO CORONARY DILATATION CATHETER WAS CHOSEN FOR TREATMENT OF A LESION (90 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS MID RCA. AFTER BALLOON WAS USED AND REMOVED FROM PATIENTS BODY, IT WAS ATTEMPTED TO UNSCREW THE INFLATION DEVICE FROM THE HUB BUT THE HUB BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158859 ↗
• MalfunctionJul 1, 2019Failure to Advance; Failure to Advance

  THE PANTERA PRO COULD NOT PASS THE SEVERELY HIGH CALCIFIED LESION IN THE LAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751258 ↗