Valeo® Balloon Expandable Biliary Stent EV07262CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 7 mm x 26 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000744), received between Sep 5, 2017 and Mar 19, 2024 — classified as 1 injury, 4 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
- Detachment of Device or Device Component1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY LOOSE ON THE SHAFT UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928359 ↗MalfunctionAug 21, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE, THE STENT ALLEGEDLY CAME OFF THE BALLOON INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17584415 ↗InjuryMay 6, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A BALLOON EXPANDABLE STENT PLACEMENT IN THE LEFT COMMON ILIAC ARTERY, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT A SNARE DEVICE WAS USED TO RETRIEVE THE DETACHED SEGMENT; HOWEVER, IT WAS UNSUCCESSFUL. REPORTEDLY, THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO EXTRACT THE STENT THROUGH THE SHEATH. MEDICAL INTERVENTION WAS REQUIRED TO SUCCESSFULLY REMOVE THE STENT. PATIENT¿S STATUS IS UNKNOWN.
Patient problems: Injury
MAUDE report 10030678 ↗MalfunctionMar 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING TREATMENT, THE BALLOON EXPANDABLE STENT DISLODGED FROM THE BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9886899 ↗MalfunctionSep 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT UPON REMOVAL FROM THE DEVICE PACKAGING, THE BALLOON EXPANDABLE STENT WAS ALLEGEDLY DISLODGED FROM THE BALLOON. ANOTHER BALLOON EXPANDABLE STENT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6843861 ↗
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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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