VIATRAC 1008189-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08717648056826), received between Nov 2, 2016 and Sep 9, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE CAROTID ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 4X20MM VIATRAC BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER VIATRAC BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009860 ↗
• MalfunctionJul 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN STENT RESTENOSIS IN THE RIGHT CAROTID ARTERY WITH HEAVY CALCIFICATION. THE 4X20MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A JADE BALLOON WAS USED FOLLOWED BY IMPLANTATION OF A XACT STENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580467 ↗
• MalfunctionMar 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT INTERNAL CAROTID ARTERY. A 6FRENCH (FR) GUIDING SHEATH AND AN EMBOSHIELD NAV 6 WERE INSERTED WITHOUT ISSUES. THE 4.0X20MM VIATRAC BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED WITHOUT RESISTANCE. THE BALLOON WAS INFLATED ONCE AT 9 ATMOSPHERES (ATMS). UPON REMOVAL, IT WAS NOTED THAT THE BALLOON BURST DUE TO BLOOD IN THE BALLOON AND BLOOD WENT BACK IN THE INDEFLATOR. STROKE SYMPTOMS STARTED SHOWING SOON AFTER. INTRAVENOUS NITROGLYCERIN WAS ADMINISTERED. THE PROCEDURE CONTINUED WITH AN XACT STENT SUCCESSFULLY BEING IMPLANTED WITHOUT ISSUES. POST DILATATION WAS PERFORMED USING ANOTHER 5.5X20 VIATRAC BDC WITHOUT ISSUES. THE EMBOSHIELD NAV 6 FILTER WAS REMOVED WITHOUT ISSUES. THE STROKE SYMPTOMS RESOLVED AFTER THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE VIATRAC BDC AND ALL OTHER ABBOTT DEVICES USED DID NOT CAUSE OR CONTRIBUTE TO THE STROKE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507612 ↗
• 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 16325270 ↗
• MalfunctionSep 6, 2022Deformation Due to Compressive Stress; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING DEVICE PREPARATION AND BEFORE USE, AFTER FLUSHING THE DEVICE AND DURING INSERTION ONTO THE 014 GUIDEWIRE, IT WAS NOTED THAT THE VIATRAC BALLOON TIP WAS DAMAGED. DEVICE ANALYSIS NOTED THAT THE DISTAL TIP OF THE BDC WAS TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366597 ↗
• MalfunctionApr 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE VIATRAC BALLOON DILATATION CATHETER (BDC) WAS PREPPED WITH NO ISSUES OBSERVED. DURING THE PROCEDURE TO TREAT THE MODERATELY TORTUOUS AND CALCIFIED INTERNAL CAROTID ARTERY, THE BDC WAS ADVANCED TO THE LESION, BUT WHEN ATTEMPTING TO PULL NEGATIVE, IT WAS OBSERVED THE BALLOON WAS ALREADY RUPTURED. THEREFORE, THE DEVICE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 4.0 X 20 VIATRAC BDC WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196282 ↗
• MalfunctionMar 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE 4.0X20 MM VIATRAC BALLOON WAS USED WHILE EXPIRED. 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 13743300 ↗
• MalfunctionJul 20, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, 80% STENOSED INTERNAL CAROTID ARTERY. THE FIRST 4.0 X 20 MM VIATRAC DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING THE FIRST INFLATION TO 6 ATMOSPHERES (ATM), LEAKING WAS NOTED. THE DEVICE WAS REMOVED. A SECOND 4.0 X 20 MM VIATRAC DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, LEAKING WAS ALSO NOTED WHEN INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL DILATATION CATHETER OF THE SAME SIZE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200080 ↗
• MalfunctionJul 20, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, 80% STENOSED INTERNAL CAROTID ARTERY. THE FIRST 4.0 X 20 MM VIATRAC DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, DURING THE FIRST INFLATION TO 6 ATMOSPHERES (ATM), LEAKING WAS NOTED. THE DEVICE WAS REMOVED. A SECOND 4.0 X 20 MM VIATRAC DILATATION CATHETER WAS ADVANCED TO THE LESION WITHOUT ISSUE; HOWEVER, LEAKING WAS ALSO NOTED WHEN INFLATED TO 6 ATM. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL DILATATION CATHETER OF THE SAME SIZE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200078 ↗
• MalfunctionJul 7, 2020Inflation Problem; Leak/Splash; Off-Label Use; Inflation Problem; Leak/Splash; Off-Label Use

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT INTERNAL CAROTID ARTERY. A 4X20MM RX VIATRAC PLUS DILATATION CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE. THE DILATATION CATHETER WAS ADVANCED AND AN ATTEMPT TO INFLATE THE BALLOON WAS MADE AND AN INCREASE OF ATMOSPHERE¿S ON THE INDEFLATOR WAS NOTED; HOWEVER, THE BALLOON FAILED TO INFLATE AND NO CONTRAST WAS NOTED IN THE BALLOON. A LEAK WAS SUSPECTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 4X20MM RX VIATRAC PLUS DILATATION CATHETER. 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 10242291 ↗
• MalfunctionDec 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT COMMON ILIAC ARTERY. THE 4.0 X 20 MM VIATRAC DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE FIRST INFLATION TO 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE TARGET LESION WAS STENTED AND BALLOONED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203829 ↗
• MalfunctionFeb 12, 2018Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE INTERNAL CAROTID ARTERY. ON (B)(6) 2018, A 4X20X135MM VIATRAC PLUS BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED DURING FIRST INFLATION AT 4 ATMOSPHERES. A 7-10X40MM ACCULINK STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT BEING GIVEN PLAVIX POST-PROCEDURE. THE PATIENT HAD A SEIZURE OVERNIGHT AND A COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE ACCULINK STENT. THE PATIENT IS IN STABLE CONDITION AND IS GOING BACK TO THE CATH LAB ON (B)(6) 2018 TO HAVE A COVERED STENT IMPLANTED TO TREAT THE THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265207 ↗
• MalfunctionNov 2, 2016Leak/Splash

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON CAROTID ARTERY. DURING PREPARATION OF THE 5.0 X 20 MM X 135 CM VIATRAC PLUS BALLOON CATHETER, WHEN PULLING NEGATIVE DURING PREPARATION, THERE WAS AIR COMING INTO THE SYRINGE DUE TO A HOLE THAT WAS NOTED ON THE SHAFT; THEREFORE, THE DEVICE WAS NOT USED. THE 4.0 X 20 MM X 135 CM VIATRAC PLUS BALLOON CATHETER WAS NOT ABLE TO HOLD NEGATIVE PRESSURE, THERE WAS AIR COMING INTO THE SYRINGE; THEREFORE, THE DEVICE WAS NOT USED. THE 4.0 X 30 MM X 135 CM VIATRAC PLUS HAD SOME DIFFICULTY PULLING NEGATIVE, BUT WAS ABLE TO BE PREPPED . THE DEVICE WAS ADVANCED TO THE TARGET LESION, THE BALLOON INFLATED AND DEFLATED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6074247 ↗