VIATRAC 1008201-30Recalls & reported problems
Abbott Vascular Inc. · VIATRAC 14 Plus Peripheral Dilatation Catheter 7.0 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648057311), received between Sep 15, 2016 and May 31, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Expiration Issue” (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
- Device Expiration Issue1
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING PREPARATION OF THE 7X30 MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC), THE DEVICE WAS LEAKING AT THE HUB WHEN THE DEVICE WAS FLUSHED WITH SALINE. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE DEVICE WAS INFLATED OUTSIDE THE PATIENT TO CHECK THE PROBLEM. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032963 ↗MalfunctionSep 15, 2016Device Expiration Issue; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT ON (B)(6) 2016 A 7 X 30 VIATRAC PLUS WAS SUCCESSFULLY USED. IT WAS NOTED WHEN CUSTOMER SERVICE WAS PERFORMING AN SAP TRANSACTION, THE DEVICE HAD EXPIRED IN MAY 2016. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5953550 ↗
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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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