Valeo® Balloon Expandable Biliary Stent EV08362CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741000843), received between Nov 23, 2015 and May 31, 2023 — classified as 1 injury, 5 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.

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.

• MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED OFF FROM THE BALLOON WHEN TRACKING THROUGH THE SHEATH AND ARTERY, WHILE ATTEMPTING TO DEPLOY OVER TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029474 ↗
• MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED OFF FROM THE BALLOON WHEN TRACKING THROUGH THE SHEATH AND ARTERY, WHILE ATTEMPTING TO DEPLOY OVER TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ADDITIONAL STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029333 ↗
• MalfunctionDec 15, 2020Difficult to Insert; Retraction Problem; Activation Failure; Difficult to Insert; Retraction Problem; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY GOT STUCK IN THE SHEATH AND FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010406 ↗
• MalfunctionJun 29, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BALLOON EXPANDABLE STENT PLACEMENT IN THE LEFT COMMON ARTERY, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE ADVANCING THROUGH THE 7FR SHEATH. THE HEALTH CARE PROVIDER SUCCESSFULLY REMOVED 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 6679109 ↗
• InjuryApr 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 AN ANGIOPLASTY PROCEDURE IN THE RIGHT COMMON ILIAC ARTERY, THE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE ADVANCING TO THE LESION SITE. REPORTEDLY, THE HEALTH CARE PROVIDER REMOVED THE BALLOON OVER THE GUIDEWIRE FOR ANOTHER BALLOON EXPANDABLE STENT THAT WAS USED TO IMMOBILIZE THE ORIGINAL STENT TO THE VESSEL. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6497998 ↗
• MalfunctionNov 23, 2015Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED FROM THE BALLOON AS IT WAS ENTERING THE SHEATH; RENDERING THE DEVICE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5244438 ↗