VIATRAC 1008197-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648057144), received between Nov 25, 2019 and Apr 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. DURING THE USE OF A 6X20MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) A LEAK WAS NOTED AT THE QUICK-CHANGE VALVE [SHAFT] AND SUBSEQUENTLY THE BALLOON COULD NOT BE INFLATED. THEREFORE, A 6.5X20MM VIATRAC BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858500 ↗
• MalfunctionFeb 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 6X20 MM VIATRAC BALLOON DILATATION CATHETER (BDC) WAS BEING PREPPED WITH FLUSHING AND NEGATIVE PRESSURE APPLIED AND THERE WERE BUBBLES IN THE DEVICE. THIS WAS ATTEMPTED A COUPLE TIMES BUT THE BUBBLES WERE STILL PRESENT. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW VIATRAC BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21327166 ↗
• MalfunctionMay 23, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6X20X135 VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) AIR BUBBLES WERE CONTINUOUSLY NOTED FOR AT LEAST 5 MINUTES WHEN PULLING NEGATIVE. A HOLE IN THE BALLOON WAS SUSPECTED. THE BDC WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387164 ↗
• MalfunctionOct 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE HUB OF THE VIATRAC BALLOON CATHETER SEPARATED FROM THE CATHETER AS IT WAS REMOVED FROM THE HOOP. ANOTHER VIATRAC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN EH PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583387 ↗
• MalfunctionApr 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED INTERNAL CAROTID ARTERY. THE 6X20MM VIATRAC PLUS BALLOON RUPTURED AT 14ATM ON THE FIRST INFLATION. THE BALLOON CATHETER WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPLACEMENT DEVICE AS THE PROCEDURE WAS CONSIDERED TO BE COMPLETE AT THAT POINT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634835 ↗
• MalfunctionDec 20, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT TWO VIATRAC BALLOON DILATATION CATHETERS WERE PREPARED WITHOUT ISSUE. DURING A HEAVILY TORTUOUS AND CALCIFIED RIGHT INTERNAL CAROTID INTERVENTION, BOTH BALLOONS RUPTURED DURING THE FIRST INFLATION BELOW THE RATED BURST PRESSURE. TWO XACT STENT SYSTEMS WERE ADVANCED, BUT FAILED TO CROSS DUE TO THE HEAVILY CALCIFIED ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX VIATRAC PLUS 6X30 THAT WAS ABLE TO OPEN UP THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11043508 ↗
• MalfunctionNov 25, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 6.0X20MM VIATRAC PLUS BALLOON DILATATION CATHETER, WHEN PULLING NEGATIVE, CONTINUOUS AIR BUBBLES WERE NOTED. THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9369625 ↗