Valeo® Balloon Expandable Biliary Stent EV07181CDRecalls & reported problems
Bard Peripheral Vascular, Inc. · Valeo® Biliary Stent 7 mm x 18 mm (80 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
- 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 00801741000713), received between Sep 10, 2018 and Apr 19, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Device-Device Incompatibility1
- Fracture1
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.
MalfunctionApr 19, 2021Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT WAS ALLEGEDLY UNABLE TO ADVANCE THROUGH THE SHEATH AND BECAME DAMAGED. THE PROCEDURE WAS COMPLETED USING A LARGER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11684137 ↗MalfunctionOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT IN LEFT PULMONARY ARTERY STENOSIS FOR POST SURGICAL REPAIR OF CONGENITAL HEART DISEASE, ACCESSED VIA FEMORAL VEIN, THE STENT ALLEGEDLY FELT VERY TIGHT WHEN ADVANCED INTO A 6F SHEATH AND DISLODGED FROM THE BALLOON. REPORTEDLY, A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9205837 ↗MalfunctionSep 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE LEFT EXTERNAL ILIAC ARTERY VIA RIGHT COMMON FEMORAL ARTERY ACCESS SITE, THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED AND THE STENT CAME ALONG WITH THE BALLOON. REPORTEDLY, ANOTHER BALLOON EXPANDABLE STENT WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7861910 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page