Valeo® Balloon Expandable Biliary Stent EV06262CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent, 6 mm x 26 mm (120 cm delivery catheter) · Class 2 · Implant
All models of Valeo Balloon Expandable Biliary Stent (27)
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 00801741000683), received between May 7, 2020 and May 7, 2020 — 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
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, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STENT ALLEGEDLY DISLODGED FROM DELIVERY SYSTEM ABOVE THE INTENDED LESION, IN RIGHT COMMON FEMORAL ARTERY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURE¿S STENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE GOOD RESULTS ANGIOGRAPHICALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10032973 ↗
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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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