VIATRAC 1008189-40Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 4.0 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648056840), received between Apr 15, 2019 and Oct 15, 2025 — classified as 3 malfunctions.
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
- Improper or Incorrect Procedure or Method1
- Inflation Problem1
- Leak/Splash1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 13, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING PREPARATION, THE 4X40X135 RX VIATRAC BALLOON DILATATION CATHETER (BDC) WAS UNABLE TO PULL NEGATIVE PRESSURE. THEREFORE THE BDC WAS NOT USED IN THE PROCEDURE. THE BDC WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER VIATRAC BDC WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15973382 ↗MalfunctionApr 15, 2019Difficult to Remove; Difficult to Remove
IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT PROFUNDA FEMORIS ARTERY. THE VIATRAC PLUS PERIPHERAL DILATATION CATHETER WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION AND WAS INFLATED TWICE TO 10 ATMOSPHERES. NEGATIVE PRESSURE WAS HELD FOR ABOUT 30 SECONDS BETWEEN EACH INFLATION TO DEFLATE THE BALLOON. THE BALLOON WAS FULLY DEFLATED UPON REMOVAL; HOWEVER, DURING WITHDRAWAL OF THE DEVICE THERE WAS RESISTANCE BETWEEN THE BALLOON CATHETER AND .014 NON-ABBOTT GUIDE WIRE. THE BALLOON CATHETER WAS STUCK AND COULD NOT BE RETRACTED. THE GUIDE WIRE LOST VESSEL PLACEMENT; THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS FINISHED AT THIS POINT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8514894 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page