Valeo® Balloon Expandable Biliary Stent EV06181CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741000652), received between Apr 5, 2017 and Jul 17, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO STENT PLACEMENT PROCEDURE, AFTER PREPPING AND LOADING THE DEVICE ON THE WIRE, THE STENT ALLEGEDLY APPEARED TO BE PARTIALLY DISLODGED FROM THE BALLOON. IT WAS FURTHER REPORTED THAT DEVICE WAS NEVER PASSED 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 17331626 ↗
• MalfunctionJul 29, 2020Detachment 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, THE STENT ALLEGEDLY DISLODGED AND STUCK IN THE SHEATH. IT WAS FURTHER REPORTED THAT A SHEATH, STENT AND BALLOON WERE REMOVED FROM PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10337992 ↗
• MalfunctionMay 18, 2020Entrapment of Device; Detachment of Device or Device Component

  WHILE POSITIONING STENT IN PATIENT THE STENT CAME OFF THE BALLOON. STENT WAS LODGED IN THE SHEATH REQUIRING SHEATH AND BALLOON TO BE REMOVED FROM PATIENT AND A NEW SHEATH PLACED. STENT WAS REMOVED FROM PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10065031 ↗
• MalfunctionApr 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A BALLOON EXPANDABLE STENT IN TO THE LEFT PULMONARY ARTERY, IT WAS ALLEGED THAT THE STENT PREMATURELY DISLODGED AT THE HEMOSTASIS VALVE OF THE SHEATH. REPORTEDLY, ANOTHER BALLOON EXPANDABLE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6461267 ↗