Valeo® Balloon Expandable Biliary Stent EV10171CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 10 mm x 17 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741000935), received between Jan 23, 2017 and Jan 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Difficult to Insert3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- 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.
MalfunctionJan 28, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE VIA THE RIGHT FEMORAL ARTERY, THE STENT ALLEGEDLY PUSHED BACK OFF THE BALLOON ON THE DELIVERY SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY NOT ENTERED THROUGH THE VALVE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18593039 ↗MalfunctionAug 11, 2023Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY PUSHED BACK OFF THE BALLOON. IT WAS FURTHER REPORTED THAT THE STENT WAS NEVER ABLE TO PASS THROUGH VALVE ITSELF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17508825 ↗MalfunctionJan 23, 2017Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A VASCULAR STENT PLACEMENT IN THE SUBCLAVIAN ARTERY, THE BALLOON EXPANDABLE STENT WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6271331 ↗
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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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