VIATRAC 1008189-15Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 4.0 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 08717648056819), received between Apr 19, 2019 and Apr 19, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Difficult to Remove1
- Material Separation1
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.
MalfunctionApr 19, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS AND CALCIFIED LESION IN THE RENAL ARTERY. A 6F JR4-SHAPED NON-ABBOTT GUIDE CATHETER AND SPARTACORE GUIDE WIRE WERE ADVANCED IN THE PATIENT ANATOMY WITHOUT ISSUE. A 4.0X15MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED TO THE LESION AND INFLATED ONCE TO 8 ATMOSPHERES. THE BDC WAS FULLY DEFLATED AND ATTEMPTED TO BE REMOVED WHEN THE BDC BECAME STUCK ON THE GUIDE WIRE. FORCE WAS USED, AND THE DISTAL PORTION OF THE GUIDE WIRE SEPARATED AND A PORTION OF THE BDC BALLOON SEPARATED. DUE TO THE LONG (300CM) GUIDE WIRE, SCISSORS WERE THEN USED TO CUT OFF THE DISTAL 1/3 PORTION OF THE GUIDE WIRE FOR EASE OF HANDLING, AND BOTH THE PROXIMAL PORTION OF THE GUIDE WIRE AND THE BDC (INCLUDING THE SEPARATED BALLOON) WERE REMOVED FROM THE PATIENT ANATOMY. THE PRE-PLACED GUIDE CATHETER WAS THEN ADVANCED FORWARD IN THE PATIENT ANATOMY, AND THE SEPARATED PORTION OF THE GUIDE WIRE WAS ABLE TO BE RETRIEVED FROM WITHIN THE GUIDE CATHETER AND WAS COMPLETELY REMOVED FROM THE PATIENT ANATOMY. IT WAS CONFIRMED THAT NO PART OF THE BDC NOR GUIDE WIRE REMAINED IN THE PATIENT ANATOMY. A WHISPER ES GUIDE WIRE AND 5.0X15MM HE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8532771 ↗
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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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