Valeo® Balloon Expandable Biliary Stent EV08562CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 8 mm x 56 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741000867), received between Sep 18, 2020 and Apr 2, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Dislocated5
- Break1
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT WAS ALLEGEDLY DISLODGED FROM THE BALLOON WHEN TRIED TO POSITION IN THE TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749823 ↗MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED OFF FROM THE BALLOON WHEN TRACKING THROUGH THE SHEATH AND ARTERY, WHILE ATTEMPTING TO DEPLOY OVER TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029905 ↗MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED OFF FROM THE BALLOON WHEN TRACKING THROUGH THE SHEATH AND ARTERY, WHILE ATTEMPTING TO DEPLOY OVER TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029476 ↗MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED OFF FROM THE BALLOON WHEN TRACKING THROUGH THE SHEATH AND ARTERY, WHILE ATTEMPTING TO DEPLOY OVER TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029386 ↗MalfunctionAug 25, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA COMMON FEMORAL ACCESS, THE STENT ALLEGEDLY FELL OFF THE BALLOON AND GOT MANGLED CAUSED DISSECTION WHEN TRYING TO GET REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15291231 ↗MalfunctionSep 18, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE INFLATION PORTION ALLEGEDLY BROKE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 10552501 ↗
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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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