Valeo® Balloon Expandable Biliary Stent EV07362CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741000768), received between Aug 20, 2019 and Dec 12, 2022 — 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.

• MalfunctionDec 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY DISLODGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15957432 ↗
• MalfunctionJun 29, 2022Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC ARTERY, THE DEVICE ALLEGEDLY CAME OFF THE BALLOON WHEN ADVANCING THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE WAS STUCK INSIDE THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849386 ↗
• MalfunctionJun 9, 2022Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CAME OFF THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE EXPIRED. REPORTEDLY, THE DEVICE RETRIEVED AND CHANGE OUT THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641716 ↗
• MalfunctionJan 6, 2021Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY STUCK IN THE SHEATH AND HAD A RETRACTION PROBLEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122763 ↗
• MalfunctionAug 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BALLOON EXPANDABLE STENT PLACEMENT TO TREAT A SUBCLAVIAN VEIN LESION VIA LEFT BRACHIAL ACCESS ARTERY ACCESS USING AN 8F, THE STENT ALLEGEDLY CAME OFF THE BALLOON PRIOR TO DEPLOYMENT AND HAD TO BE DEPLOYED DISTAL TO THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912917 ↗