VIATRAC 1008189-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648056833), received between Oct 28, 2018 and Mar 31, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURAL PREPARATION OF A 4X30MM RX VIATRAC BALLOON DILATATION CATHETER (BDC), WHEN THE DEVICE WAS REMOVED FROM ITS PACKAGE A CLEAR AND OBVIOUS CRACK WAS NOTED AT AT THE LINK WITH THE PRESSURE SYRINGE [HUB]. THE BDC WAS REPLACED WITH ANOTHER VIATRAC 14 PLUS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY REPORTED EVENT THE DEVICE WAS RECEIVED AND A FUNCTIONAL TEST WAS PERFORMED. A LEAK WAS NOTED AT THE NOSEPIECE BREAK IN THE HUB. THE ACCOUNT CONFIRMED THAT THE LEAK WAS NOTED DURING THE INFLATION OF THE DEVICE WHILE INSIDE THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733405 ↗
• MalfunctionMar 4, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS INTERNAL CAROTID ARTERY THAT IS 70% STENOSED. AN UNSPECIFIED STENT WAS IMPLANTED AND THE 4.0X30MM VIATRAC PLUS PERIPHERAL BALLOON DILATATION CATHETER (BDC) WAS ADVANCED. RESISTANCE WAS NOTED WITH THE ANATOMY. THE VIATRAC SUCCESSFULLY CROSSED THE LESION AND WAS INFLATED FOR POST-DILATATION BUT RUPTURED AT 11 ATMOSPHERES DURING THE FIRST INFLATION. A NEW 4.0X30MM VIATRAC PLUS BDC WAS USED TO COMPLETE THE PROCEDURE. 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 21516421 ↗
• MalfunctionFeb 11, 2025Material Separation; Material Separation

  SUBSEQUENT TO THE FILED INITIAL REPORT, IT WAS NOTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, INTERNAL CAROTID ARTERY THAT IS 80% STENOSED. DURING REMOVAL THE 4.0X30MM VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER HUB WAS NOTED TO BE SEPARATED INTO TWO PIECES; HOWEVER, WAS SIMPLY WITHDRAWN. 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 21358141 ↗
• MalfunctionNov 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE ONCE THE 4X30X135 VIATRAC PLUS BALLOON DILATATION CATHETER OPENED THE TAPERED TIP WAS OBSERVED TO BE SEPARATED. THEREFORE, A NEW UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790939 ↗
• MalfunctionJul 8, 2024Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE LEFT INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 4X30MM VIATRAC BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION; HOWEVER, WHEN THE BALLOON WAS INFLATED ONCE TO 3 ATMOSPHERES (ATM) A LEAK WAS NOTED. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER VIATRAC BALLOON WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697390 ↗
• MalfunctionMay 3, 2024Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH 80% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X30MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS UNABLE TO PASS THROUGH THE LESION. WHEN PREPARING TO ADJUST THE GUIDE WIRE, IT WAS FOUND THAT THERE WAS A HOLE IN THE CATHETER AT THE TIP OF THE BALLOON, AND THE GUIDE WIRE PASSED THROUGH THE HOLE OF THE TIP OF THE BALLOON. ANOTHER SAME SIZE VIATRAC BALLOON WAS USED AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243207 ↗
• MalfunctionDec 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE LEFT INTERNAL CAROTID ARTERY. A 4X30X135MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, UPON INFLATION A LARGE NUMBER OF BUBBLES WERE NOTED. THE BDC WAS REMOVED AND WHEN TESTED IN VITRO, A LEAK WAS NOTED IN THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965657 ↗
• MalfunctionSep 21, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE INTERNAL CAROTID ARTERY THAT WAS HEAVILY CALCIFIED. THE VIATRAC BALLOON RUPTURED DURING THE FIRST INFLATION BELOW NOMINAL PRESSURE. IT IS NOT KNOWN WHAT DEVICE WAS USED TO CONTINUE THE PROCEDURE. HOWEVER, THERE WERE NO REPORTED 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 12509768 ↗
• 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 11043507 ↗
• MalfunctionDec 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE OUTER PACKAGE LABELING DID NOT MATCH THE INNER PACKAGE PRODUCT OF 5 VIATRAC PLUS BALLOON DILATATION CATHETERS. THE OUTER PACKAGES WERE LABELED AS VIATRAC PLUS 4X30MM 135CM BUT THE DEVICES IN THE PACKAGES WERE 6X30MM 135 CM. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 11016839 ↗
• MalfunctionDec 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE OUTER PACKAGE LABELING DID NOT MATCH THE INNER PACKAGE PRODUCT OF 5 VIATRAC PLUS BALLOON DILATATION CATHETERS. THE OUTER PACKAGES WERE LABELED AS VIATRAC PLUS 4X30MM 135CM BUT THE DEVICES IN THE PACKAGES WERE 6X30MM 135 CM. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 11016835 ↗
• MalfunctionDec 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE OUTER PACKAGE LABELING DID NOT MATCH THE INNER PACKAGE PRODUCT OF 5 VIATRAC PLUS BALLOON DILATATION CATHETERS. THE OUTER PACKAGES WERE LABELED AS VIATRAC PLUS 4X30MM 135CM BUT THE DEVICES IN THE PACKAGES WERE 6X30MM 135 CM. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 11016779 ↗
• MalfunctionDec 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE OUTER PACKAGE LABELING DID NOT MATCH THE INNER PACKAGE PRODUCT OF 5 VIATRAC PLUS BALLOON DILATATION CATHETERS. THE OUTER PACKAGES WERE LABELED AS VIATRAC PLUS 4X30MM 135CM BUT THE DEVICES IN THE PACKAGES WERE 6X30MM 135 CM. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 11016778 ↗
• MalfunctionDec 16, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE OUTER PACKAGE LABELING DID NOT MATCH THE INNER PACKAGE PRODUCT OF 5 VIATRAC PLUS BALLOON DILATATION CATHETERS. THE OUTER PACKAGES WERE LABELED AS VIATRAC PLUS 4X30MM 135CM BUT THE DEVICES IN THE PACKAGES WERE 6X30MM 135 CM. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 11016762 ↗
• MalfunctionOct 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PART NUMBER ON THE INTERNATIONAL LABEL (CHINESE) OF A 4X30MM RX VIATRAC PLUS PERIPHERAL DILATATION CATHETER DID NOT MATCH THE PART NUMBER ON THE ENGLISH LABEL ON THE BOX. THE DILATION CATHETER WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8011639 ↗