VIATRAC 1008193-40Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 5.0 mm x 40 mm x 135 cm · Class 2
All models of VIATRAC (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648057007), received between Oct 19, 2023 and Oct 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Rupture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2023Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE LEFT COMMON CAROTID ARTERY WITH HEAVY CALCIFICATION AT THE BIFURCATION. PUNCTURE WAS AT THE RIGHT FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED USING A 4.0X20MM VIATRAC BALLOON. AN EMBOSHIELD NAV 6 FILTER WAS POSITIONED AND A 7.0-9.0X40MM XACT CAROTID STENT SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. ANOTHER 5.0X40MM VIATRAC BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE TO THE LESION AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATMS). HOWEVER, THE BALLOON "STRIPPED" ON THE CALCIFICATION AND SEPARATED WITH THE DISTAL PART REMAINING IN THE ANATOMY DISTAL TO THE TIP OF THE INTRODUCER DURING REMOVAL. AN ATTEMPT TO REMOVE ALL THE DEVICES WAS MADE INCLUDING THE GUIDE CATHETER, EMBOSHIELD NAV 6 FILTER AND THE SEPARATED PORTION OF THE BALLOON USING THE GUIDE WIRE IN PLACE BUT FAILED AS THE DEVICES REMAINED BLOCKED DUE TO THE ISSUE WITH THE BALLOON. THE PROCEDURE WAS IMMEDIATELY CONVERTED TO AN OPEN SURGERY FOR A CAROTID-CAROTID BYPASS. NOTHING REMAINS IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. N
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17966046 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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