VIATRAC 1008193-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648056994), received between Dec 6, 2017 and Sep 18, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X30MM RX VIATRAC PERIPHERAL BALLOON CATHETER, IT WAS NOTED THE HUB WAS CRACKED THERE THE BALLOON COULD NOT INFLATE. ANOTHER VIATRAC 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 20246197 ↗
• MalfunctionAug 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 5.0X30MM VIATRAC PLUS BALLOON PERIPHERAL DILATATION CATHETER WAS PREPPED PER INSTRUCTIONS FOR USE. THE BALLOON WAS ADVANCED WITHOUT RESISTANCE AND INFLATED ONCE TO 10 ATMOSPHERES WHEN A RUPTURE OCCURRED. A SAME SIZE DEVICE WAS USED TO CONTINUE 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 20102222 ↗
• MalfunctionOct 30, 2023Material Rupture; 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, MILDLY TORTUOUS AND 80% STENOSED. REPORTEDLY, THE 5.0X30MM VIATRAC PLUS DILATATION CATHETER WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUES. THERE WAS NO RESISTANCE DURING ADVANCEMENT TO THE LESION. WHEN THE BALLOON WAS PRESSURED TO 10 ATMOSPHERES, IT RUPTURED DURING THE 1ST INFLATION. A SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030660 ↗
• MalfunctionOct 10, 2023Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED DE NOVO LESION IN THE ILIAC ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 5.0X30MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED ONE TIME TO 10 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOON, AND ALTHOUGH THE BALLOON COMPLETELY DEFLATED, IT DID NOT REWRAP/REFOLD TIGHTLY. THERE WAS DIFFICULTY REMOVING THE BDC DUE TO THE POOR REFOLD; THEREFORE, THE BDC WAS REMOVED TOGETHER WITH THE SHEATH AS A SINGLE UNIT. 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 17909437 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE CAROTID ARTERY AND THE CAROTID BULB WAS VERY CALCIFIED. THE 5X30X135 MM VIATRAC AND 4X20X135 MM VIATRAC BALLOON DILATATION CATHETERS (BDC) RUPTURED WHEN THEY WERE INFLATED TO THE RATED BURST PRESSURE AT 14 ATMOSPHERES. THE BALLOONS WERE PREPPED OUTSIDE THE ANATOMY PRIOR TO USE AND THERE WAS NO RESISTANCE DURING ADVANCEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS 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 16325202 ↗
• InjurySep 13, 2021Off-Label Use; Difficult to Remove; Material Rupture; Material Separation; Off-Label Use; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN CAROTID ARTERY. THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE DISTAL END OF THE STENOSIS AND IT WAS DECIDED BY THE PHYSICIAN TO USE A 5X30X135 VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER AS THERE WAS NO OTHER SUITABLE BALLOON TO CHOOSE DURING THE PROCEDURE. THE VIATRAC RUPTURED AT 14 ATMOSPHERES AND HALF OF THE BALLOON WAS WITHDRAWN FROM THE ANATOMY; HOWEVER, THE OTHER HALF REMAINED ON THE UNSPECIFIED GUIDE WIRE. THE BALLOON LEFT ON THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED WITH THE GUIDING CATHETER, BUT IT WOULD NOT ENTER THE GUIDING CATHETER. A SEPARATE SHEATH WAS ADVANCED IN ATTEMPT TO SNARE THE BALLOON; HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE FILTER AND THE BALLOON WERE REMOVED TOGETHER WITH THE EPS BAREWIRE. ANOTHER SAME SIZE VIATRAC AND NAV6 WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459750 ↗
• MalfunctionFeb 26, 2020Off-Label Use; Material Rupture; Difficult to Advance; Off-Label Use; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON CAROTID ARTERY. A 5X30MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WITH THE HEAVY CALCIFICATION DURING ADVANCEMENT AND RUPTURED AT 5 ATMOSPHERES DURING THE FIRST INFLATION. A 4.0X30MM TREK RX BDC ALSO MET RESISTANCE DURING ADVANCEMENT AND RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. AN 8X25MM NON-ABBOTT STENT WAS THEN IMPLANTED AND POST-DILATED TO SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 9759344 ↗
• MalfunctionNov 1, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CLARIFICATION: THE LABEL DISCREPANCY WAS NOTED AT THE DISTRIBUTOR IN (B)(6).

  Patient problems: No Patient Involvement

  MAUDE report 8030103 ↗
• MalfunctionNov 1, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CLARIFICATION: THE LABEL DISCREPANCY WAS NOTED AT THE DISTRIBUTOR IN (B)(6).

  Patient problems: No Patient Involvement

  MAUDE report 8029934 ↗
• MalfunctionNov 1, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  CLARIFICATION: THE LABEL DISCREPANCY WAS NOTED AT THE DISTRIBUTOR IN (B)(6).

  Patient problems: No Patient Involvement

  MAUDE report 8029917 ↗
• MalfunctionDec 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LEFT INTERNAL TO COMMON CAROTID ARTERY. AN ACCULINK STENT WAS IMPLANTED. A 5 X 30 MM VIATRAC PLUS BALLOON CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE TO PERFORM POST-DILATATION WHEN THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES. THE PATIENT STARTED SHOWING NEUROLOGICAL DEFICIENCY ON THE RIGHT SIDE WITH WEAKNESS IN THE ARM AND THE LEG. THIRTY MINUTES LATER THE SYMPTOMS WENT AWAY. ANGIOGRAM WAS TAKEN AND THE STENT WAS FULLY EXPANDED SO THE PROCEDURE WAS COMPLETED AT THIS TIME. AN MRI WAS PERFORMED SHOWING NO SIGN OF AIR EMBOLIZATION IN THE BRAIN. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Neurological Deficit/Dysfunction; Weakness

  MAUDE report 7088769 ↗