Valeo® Balloon Expandable Biliary Stent EV06261CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent, 6 mm x 26 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 00801741000676), received between Sep 7, 2020 and Aug 23, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Failure to Advance2
- Device Dislodged or Dislocated1
- Migration1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration; Detachment of Device or Device Component; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF THE BALLOON AND MIGRATED TO ILIAC. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15273716 ↗MalfunctionSep 7, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE OVER THE LESION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DETACHED. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499011 ↗MalfunctionSep 7, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO ADVANCE OVER THE LESION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY DETACHED. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10499009 ↗
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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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