Valeo® Balloon Expandable Biliary Stent EV08262CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741000829), received between Nov 17, 2017 and Apr 14, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2024Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY VIA THE CONTRALATERAL FEMORAL ACCESS, WHEN THE PHYSICIAN WAS GOING TO PASS THE STENT THROUGH THE SHEATH, THE STENT ALLEGEDLY DISLODGED AND CAME OFF THE BALLOON AT THE SHEATH VALVE. IT WAS FURTHER REPORTED THAT WHEN ATTEMPTED TO PUT THE STENT BACK THROUGH THE SHEATH, THE STENT ALLEGEDLY CRIMPED BETWEEN THE PHYSICIAN'S FINGER AND THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103022 ↗
• MalfunctionSep 18, 2023Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE EXTERNAL ILIAC ARTERY VIA THE COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY GOT CAUGHT IN VALVE OF SHEATH WHEN TRIED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE STENT WAS NOT VERY TIGHT ON THE BALLOON EITHER AND SLID OFF WAY TOO EASY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765296 ↗
• InjuryFeb 24, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY DISLODGED FROM THE SHEATH. IT WAS FURTHER REPORTED THAT STENT ALLEGEDLY MIGRATED TO THE ILIAC. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16434500 ↗
• MalfunctionApr 6, 2020Difficult to Insert; Retraction Problem; Device Dislodged or Dislocated; Difficult to Insert; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DELIVERY SYSTEM ALLEGEDLY BECOME STUCK WHEN ATTEMPTING TO ADVANCE THROUGH A 6FR SHEATH. UPON REMOVAL, THERE WERE DIFFICULTIES RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT AND THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931545 ↗
• 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 9886858 ↗
• MalfunctionNov 17, 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 A BALLOON EXPANDABLE STENT PLACEMENT IN THE COMMON ILIAC ARTERY, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE ADVANCING THROUGH THE SHEATH. THE HEALTH CARE PROVIDER USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE STENT AND DELIVERY SYSTEM FROM THE PATIENT AND DEPLOYED ANOTHER STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040838 ↗