Valeo® Balloon Expandable Biliary Stent EV08181CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741000799), received between Apr 17, 2018 and Aug 5, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911380 ↗
• MalfunctionFeb 12, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION FOR A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DOES NOT FIT INTO THE SHEATH AND FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY SHEARING OFF FROM THE BALLOON WHEN INSERTED INTO THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18683150 ↗
• MalfunctionJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME OFF OF THE BALLOON PRIOR TO DEPLOYMENT AND IT WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412344 ↗
• MalfunctionFeb 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY SLIPPED OFF BALLOON PART BACK INTO 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 16452077 ↗
• MalfunctionFeb 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY SLIPPED OFF BALLOON PART BACK INTO 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 16451969 ↗
• MalfunctionJan 6, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT PULMONARY ARTERY, THE STENT ALLEGEDLY DISLODGED FROM BALLOON. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED ALONG WITH THE ENTIRE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110661 ↗
• MalfunctionDec 8, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE STENT ALLEGEDLY FAILED TO INSERT THROUGH SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964208 ↗
• MalfunctionNov 5, 2019Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BALLOON EXPANDABLE STENT PLACEMENT VIA RIGHT FEMORAL VEIN ACCESS, THE STENT ALLEGEDLY MIGRATED OFF THE BALLOON AND BEGAN TO BEND AFTER ADVANCING INTO THE INTRODUCER SHEATH. REPORTEDLY, A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280655 ↗
• MalfunctionApr 17, 2018Difficult to Insert; Kinked; Device Dislodged or Dislocated; Difficult to Insert; Kinked; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING ADVANCEMENT OF A BALLOON EXPANDABLE STENT THROUGH THE HEMOSTATIC VALVE OF AN INTRODUCER SHEATH (OTHER MANUFACTURER), THE STENT HAD ALLEGEDLY KINKED AND DISLODGED FROM THE BALLOON; HOWEVER, IT REMAINED ON THE CATHETER. REPORTEDLY, THE ENTIRE SYSTEM WAS REMOVED AND THE HEALTH CARE PROVIDER USED ANOTHER BALLOON EXPANDABLE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7438882 ↗