VIATRACRecalls & reported problems across all models
Abbott Vascular Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 22 models of VIATRAC by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Sep 15, 2016 and Aug 6, 2026 — classified as 8 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (40 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VIATRAC problems
Device problems
- Material Rupture40
- Leak/Splash16
- Material Separation12
- Off-Label Use10
- Device Markings/Labelling Problem9
- Difficult to Remove8
- Improper or Incorrect Procedure or Method8
- Difficult to Advance4
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient15
- No Patient Involvement12
- Coma1
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Neurological Deficit/Dysfunction1
VIATRAC models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VIATRAC 1008189-30Catheter, angioplasty, peripheral, transluminal15 reports
- VIATRAC 1008189-20Catheter, angioplasty, peripheral, transluminal13 reports
- VIATRAC 1008193-20Catheter, angioplasty, peripheral, transluminal11 reports
- VIATRAC 1008193-30Catheter, angioplasty, peripheral, transluminal11 reports
- VIATRAC 1008197-20Catheter, angioplasty, peripheral, transluminal7 reports
- VIATRAC 1008189-40Catheter, angioplasty, peripheral, transluminal3 reports
- VIATRAC 1008201-20Catheter, angioplasty, peripheral, transluminal3 reports
- VIATRAC 1008201-30Catheter, angioplasty, peripheral, transluminal2 reports
- VIATRAC 1008189-15Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008190-30Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008191-15Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008193-40Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008194-20Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008194-30Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008194-40Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008195-15Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008195-20Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008195-40Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008197-30Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008197-40Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008198-20Catheter, angioplasty, peripheral, transluminal1 report
- VIATRAC 1008198-30Catheter, angioplasty, peripheral, transluminal1 report
Recent VIATRAC adverse event reports
The 15 most recent reports across all models, 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 24, 2026Difficult to Insert; Leak/Splash; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING PREPARATION, THE PHYSICIAN WAS UNABLE TO THREAD A GUIDE WIRE THROUGH A 5X20 MM VIATRAC 14 PLUS BALLOON DILATION CATHETER, CAUSING THE TIP TO BECOME BENT. THERE WAS NO PATIENT INVOLVEMENT. A USER FACILITY MEDWATCH REPORT WAS RECEIVED THAT STATES: TIP DRAINAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676911 ↗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 ↗MalfunctionOct 15, 2025Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method
SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE BDC WAS NOT PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302207 ↗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 ↗MalfunctionAug 15, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA). FOLLOWING PRE-TREATMENT OF THE VESSEL WITH A DIAMONDBACK ORBITAL ATHERECTOMY DEVICE, A 6X40MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THROUGH A 7FR SHEATH; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION TO 6ATMS. THE BDC WAS REPLACED WITH AN ARMADA 18 BDC AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22820157 ↗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 ↗MalfunctionJun 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT INTERNAL CAROTID WITH HEAVY CALCIFICATION. THE VIATRAC BALLOON WAS USED SUCCESSFULLY FOR PRE-DILATATION. THE SAME BALLOON WAS USED FOR POST DILATATION AFTER A NON-ABBOTT STENT WAS IMPLANTED; HOWEVER, THE BALLOON RUPTURED AT RATED BURST PRESSURE (RBP). THE BALLOON WAS REMOVED INTACT AND WITHOUT ISSUES 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 22189315 ↗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 ↗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 ↗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 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page