VIATRAC 1008195-15Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 5.5 mm x 15 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648057052), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT THE VIATRAC BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR PRE-DILATATION IN THE SEVERELY CALCIFIED RIGHT INTERNAL CAROTID ARTERY. THE BDC WAS INFLATED ONCE AND RUPTURED AROUND 8 ATMOSPHERES. A NEW VIATRAC BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10570877 ↗
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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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