Valeo® Balloon Expandable Biliary Stent EV08182CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 8 mm x 18 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000805), received between May 11, 2017 and Feb 20, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
- Component Missing1
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
- Difficult to Insert1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO FIT THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY GOT SLIPPED OFF AT THE HEMOVALVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738585 ↗MalfunctionOct 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF THE CATHETER BEFORE INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939804 ↗MalfunctionMay 3, 2021Retraction Problem; Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material; Retraction Problem; Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A STENT PLACEMENT, THE DEVICE ALLEGEDLY CONTAMINATED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11759699 ↗MalfunctionApr 30, 2021Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT, THE STENT ALLEGEDLY MISSING FROM THE PACKAGE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11751290 ↗MalfunctionMay 11, 2017Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERIOR VENA CAVA, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE ADVANCING THROUGH THE SHEATH. ANOTHER BALLOON AND A LARGER SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6561687 ↗
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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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