Valeo® Balloon Expandable Biliary Stent EV08561CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000850), received between Aug 21, 2018 and Feb 22, 2023 — 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN ILIAC ARTERY VIA COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY CAME DISLODGED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415448 ↗
• MalfunctionJun 3, 2021Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT ALLEGEDLY HAD DIFFICULT TO PASS THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928863 ↗
• MalfunctionFeb 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED FROM THE BALLOON BEFORE EXITING THE INTRODUCER SHEATH WHILE TREATING THE RIGHT COMMON/EXTERNAL ILIAC. THE STENT WAS SUCCESSFULLY PULLED OUT WITH THE BALLOON CATHETER AND ANOTHER BALLOON EXPANDABLE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670771 ↗
• MalfunctionAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE ILIAC ARTERY, THE STENT GRAFT ALLEGEDLY DISLODGED FROM THE DELIVERY SYSTEM WHILE BEING INSERTED THROUGH THE INTRODUCER SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947125 ↗
• MalfunctionAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY, THE STENT BECAME DISLODGED FROM THE BALLOON PRIOR TO ENTERING THE SHEATH. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803616 ↗