Valeo® Balloon Expandable Biliary Stent EV06361CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent, 6 mm x 36 mm (80 cm delivery catheter) · Class 2 · Implant
All models of Valeo Balloon Expandable Biliary Stent (27)
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 00801741000690), received between Apr 2, 2024 and Sep 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Difficult to Insert1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210025 ↗MalfunctionApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY THROUGH THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY PARTIALLY DISLODGED UPON ATTEMPTED DELIVERY. REPORTEDLY, THE STENT WAS REMOVED ALONG WITH THE STENT BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19017555 ↗
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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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