Valeo® Balloon Expandable Biliary Stent EV08261CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741000812), received between Jan 8, 2016 and Jan 8, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463373 ↗
• MalfunctionMay 25, 2023Unraveled Material; Device Dislodged or Dislocated; Material Deformation; Unraveled Material; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT COMMON ILIAC ARTERY, THE STENT ALLEGEDLY CAME OFF THE BALLOON MOUNTED ON AT THE SHEATH HUB AND THE STENT NEVER MADE IT INTO THE SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON/STENT WAS TRIED TO PUT INTO THE HUB OF THE SHEATH AND THE STENT CAME OFF THE BALLOON OUTSIDE OF THE PATIENT. THE PROCEDURE WAS ENDED UP BALLOONING THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000652 ↗
• MalfunctionMay 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DISLODGED AND STARTED MOVING ON THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14300512 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DISLODGED FROM THE BALLOON INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON WAS USED TO DEPLOY THE STENT IN CORRECT POSITION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12405731 ↗
• MalfunctionNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STENT WAS CAME OFF BEFORE BALLOON DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910217 ↗
• MalfunctionJul 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF THE LEFT EXTERNAL ILIAC ARTERY VIA RIGHT COMMON FEMORAL ACCESS, THE HEALTHCARE PROVIDER INSERTED THE STENT HALFWAY THROUGH THE INTRODUCER SHEATH AND THEN DECIDED TO REMOVE THE DELIVERY SYSTEM TO CHANGE THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT AS THE DELIVERY SYSTEM WAS BEING PULLED BACK THROUGH THE INTRODUCER SHEATH, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON AND REMAINED ON THE CATHETER. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE THROUGH THE SAME ACCESS SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804014 ↗
• MalfunctionJan 8, 2016Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED DURING INSERTION INTO THE SHEATH; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5355164 ↗
• MalfunctionJan 8, 2016Difficult to Insert; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED DURING INSERTION INTO THE SHEATH; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5354843 ↗