Vaccess® VA8074RRecalls & reported problems
Bard Peripheral Vascular, Inc. · Vaccess® PTA Dilatation Catheter 7 mm x 40 mm, 80 cm Catheter · Class 2
All models of Vaccess (25)
Data updated Oct 16, 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 00801741059919), received between May 7, 2018 and May 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Rupture1
- Retraction Problem1
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.
MalfunctionMay 7, 2018Retraction Problem; Material Rupture; Detachment of Device or Device Component; Retraction Problem; Material Rupture; Detachment of Device or Device Component
IT WAS REPORTED DURING A THROMBECTOMY PROCEDURE OF THE RIGHT FOREARM GRAFT, THE PTA BALLOON WAS INFLATED IN A STENT LOCATED AT THE VENOUS ANASTOMOSIS AND RUPTURED. DURING REMOVAL OF THE BALLOON THROUGH THE SHEATH, THE BALLOON SHEARED OFF OF THE CATHETER SHAFT. THE SHEATH WAS REMOVED, THE BALLOON FRAGMENT WAS VISUALIZED AND REMOVED WITH HEMOSTATS. THE BALLOON TIP APPEARED TO BE INTACT. ANOTHER SHEATH WAS INSERTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7492655 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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