VIATRAC 1008197-30Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 6.0 mm x 30 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 08717648057151), received between Jul 25, 2024 and Jul 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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 Remove1
- Material Separation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LEFT UPPER LIMB ARTERIOVENOUS FISTULA WITH 60% STENOSIS. WITH ACCESS OBTAINED IN THE RIGHT INGUINAL FEMORAL ARTERY, ARTERIO VENOGRAPHY WAS PERFORMED AND A 6X30MM VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER WAS USED FOR DILATATION. THE BASILIC VEIN WAS VISUALIZED 5 CM PROXIMAL TO THE FISTULA, AND BALLOON DILATATION WAS AGAIN PERFORMED FOLLOWED BY AN ADDITIONAL ARTERIO VENOGRAPHY WHICH SHOWED UNOBSTRUCTED BLOOD FLOW. DURING WITHDRAWAL THERE WAS RESISTANCE AND THE BALLOON SEPARATED. ANGIOGRAPHY CONFIRMED THE BALLOON WAS FOUND AT THE DISTAL END OF THE CATHETER SHEATH. RETRIEVAL WAS ATTEMPTED BY CUT DOWN THEN SUCCESSFULLY RETRIEVED BY SNARE. PATIENT HAD SIGNIFICANT BLEEDING WHICH WAS CONTROLLED BY APPLYING MANUAL PRESSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19828513 ↗
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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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