Valeo® Balloon Expandable Biliary Stent EV07561CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 7 mm x 56 mm (80 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741000775), received between Sep 25, 2020 and Aug 7, 2024 — classified as 1 injury, 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Contamination of Device Ingredient or Reagent1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- 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.
InjuryAug 7, 2024Contamination of Device Ingredient or Reagent; Detachment of Device or Device Component; Contamination of Device Ingredient or Reagent; Detachment of Device or Device Component
IT WAS REPORTED THAT SOMETIME POST A STENT PLACEMENT, A SMALL GRAY OR BLACK FOREIGN BODY WAS ALLEGEDLY FOUND WITHIN THE BLOOD CLOT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 19935286 ↗MalfunctionApr 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, THE STENT ALLEGEDLY CAME OFF THE BALLOON IT WAS MOUNTED ON AT THE SHEATH HUB AND NEVER MADE IT INTO 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 16699207 ↗MalfunctionSep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN UPPER EXTREMITY PTA PROCEDURE IN THE RADIAL ARTERY, THE STENT ALLEGEDLY DISLODGED OFF THE BALLOON INSIDE THE SHEATH. THE WHOLE SYSTEM WAS PULLED OUT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10585343 ↗
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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 13, 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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