VIATRAC 1008193-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648056987), received between Nov 2, 2016 and Aug 6, 2026 — classified as 3 injuries, 8 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.

• MalfunctionAug 6, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165143 ↗
• MalfunctionMar 19, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON CAROTID ARTERY. THE 5X20X135MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) RUPTURED AT NOMINAL PRESSURE. A SECOND 5X20X135MM RX VIATRAC PLUS BDC ALSO RUPTURED AT NOMINAL PRESSURE. AFTER, A THIRD 5X20X135MM RX VIATRAC PLUS BDC RUPTURED AT NOMINAL PRESSURE. A FOURTH 5X20X135MM RX 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 24641837 ↗
• MalfunctionMar 19, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON CAROTID ARTERY. THE 5 X 20 X 135 MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) RUPTURED AT NOMINAL PRESSURE. A SECOND 5 X 20 X 135 MM RX VIATRAC PLUS BDC ALSO RUPTURED AT NOMINAL PRESSURE. AFTER, A THIRD 5 X 20 X 135 MM RX VIATRAC PLUS BDC RUPTURED AT NOMINAL PRESSURE. A FOURTH 5X20X135MM RX 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 24641833 ↗
• MalfunctionMar 19, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON CAROTID ARTERY. THE 5 X 20 X 135 MM RX VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) RUPTURED AT NOMINAL PRESSURE. A SECOND 5 X 20 X 135 MM RX VIATRAC PLUS BDC ALSO RUPTURED AT NOMINAL PRESSURE. AFTER, A THIRD 5 X 20 X 135 MM RX VIATRAC PLUS BDC RUPTURED AT NOMINAL PRESSURE. A FOURTH 5 X 20 X 135 MM RX 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 24641829 ↗
• MalfunctionDec 30, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION OF THE 5.0X20MM VIATRAC PLUS PERIPHERAL BALLOON DILATATION CATHETER (BDC), WHEN PULLING NEGATIVE, AIR WAS UNABLE TO BE PULLED OUT OF THE BALLOON AFTER FIVE ATTEMPTS. THEREFORE, ANOTHER VIATRAC PLUS BDC 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 21036196 ↗
• InjuryApr 13, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  USER FACILITY MEDWATCH REPORT STATES [MW5099757]: [AN RX VIATRAC 14MM PLUS PERIPHERAL DILATION CATHETER WAS BEING UTILIZED DURING A PERIPHERAL ANGIOPLASTY, 4-5 MM OF AIR HAD BEEN INSTILLED WHEN THE BALLOON BURST LEAVING A FRAGMENT OF THE DEVICE IN THE PATIENT. IS THERAPY STILL ON-GOING? NO. PERIPHERAL ANGIOPLASTY. FDA SAFETY REPORT ID# (B)(4)]NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11657152 ↗
• InjuryApr 7, 2021Difficult to Remove; Material Rupture; Material Separation; Difficult to Remove; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POPLITEAL BYPASS GRAFT WHICH WAS OCCLUDED. A 5.0X20MM VIATRAC PLUS PERIPHERAL DILATATION CATHETER WAS ATTEMPTED TO BE USED; HOWEVER, RUPTURED AT FIRST INFLATION AT 4 ATMOSPHERES. THE MARKER/STRIP BECAME SEPARATED AND WAS RETRIEVED BY A SMALL CUTDOWN. PATIENT IS DOING WELL. A CLINICALLY SIGNIFICANT DELAY WAS NOTED DUE TO THE RETRIEVAL OF THE SEPARATED PORTION. ADDITIONAL INFORMATION: DURING REMOVAL RESISTANCE WAS MET WHEN PULLING THE DEVICE BACK OVER THE UNSPECIFIED GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11631688 ↗
• MalfunctionJan 13, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS COMMON CAROTID ARTERY THAT WAS 90% STENOSED. AFTER CROSSING THE LESION WITH AN UNSPECIFIED WIRE AND AN UNSPECIFIED EMBOLIC PROTECTION DEVICE, A 5X20MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS POSITIONED. THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE, BUT THE BALLOON DID NOT OPEN TO FULL DIAMETER AS A LEAK WAS OBSERVED FROM THE HUB. THE BDC WAS REMOVED AND REPLACED WITH A NEW 5X20MM VIATRAC BALLOON 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 11164589 ↗
• MalfunctionJul 29, 2020Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RENAL ARTERY. A 5X20MM VIATRAC PLUS BALLOON WAS PLACED OVER A HI-TORQUE COMMAND GUIDE WIRE, AND RESISTANCE WAS MET WHEN ADVANCING THE BALLOON OVER THE WIRE. THEREFORE, IT WAS DECIDED TO REMOVE THE BALLOON, BUT FORCE HAD TO BE APPLIED AS RESISTANCE WAS MET, AND THE BALLOON PORTION SEPARATED. THE DEVICES WERE SIMPLY REMOVED ALTOGETHER AND IT WAS CONFIRMED THAT NOTHING REMAINED IN THE ANATOMY. ANOTHER BALLOON AND GUIDE WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT CONFIRMING THAT THE SHAFT SEPARATED, NOT THE BALLOON PORTION AS INITIALLY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337863 ↗
• InjuryMay 31, 2017Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MODERATELY TORTUOUS LEFT INTERNAL CAROTID ARTERY (LICA). AN EMBOSHIELD NAV6 LG 190CM EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED PAST THE LESION WITHOUT ISSUE. A 5X20X135 RX VIATRAC BALLOON WAS ADVANCED AND INFLATED WITHOUT DIFFICULTY WHEN, DURING INFLATION, THE PATIENT BREATHING BECAME NOTABLY VERY LABORED THEN PATIENT BECOME TOTALLY UNRESPONSIVE NEUROLOGICALLY. NO THROMBUS WAS NOTED, BUT A STROKE WAS CONFIRMED TO HAVE OCCURRED. AN 8TX40X136 XACT STENT WAS THEN SUCCESSFULLY DEPLOYED, AS PLANNED, RESULTING IN GOOD FLOW AND GOOD OVERALL RESULT, AS CONFIRMED ANGIOGRAPHICALLY AND ON COMPUTERIZED TOMOGRAPHY SCAN. THE NAV6 WAS RETRIEVED WITHOUT DIFFICULTY. NO INTERVENTIONS WERE PERFORMED. WHILE THERE WERE NO DEVICE ISSUES, THE PATIENT NEUROLOGICAL DEFICIT REMAINS AND PATIENT REMAINS COMATOSE (BUT NOT INTUBATED) AND, AS OF (B)(6) 2017, IS NOT EXPECTED TO RECOVER IN THE NEAR FUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Coma; Stroke/CVA

  MAUDE report 6603329 ↗
• MalfunctionNov 2, 2016Leak/Splash; Torn Material

  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 6074249 ↗