Valeo® Balloon Expandable Biliary Stent EV08361CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741000836), received between Sep 6, 2016 and Jan 8, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 18463375 ↗
• 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 18463374 ↗
• MalfunctionJun 27, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC COMMON VIA COMMON FEMORAL ACCESS, THE STENT ALLEGEDLY FELL OFF IN PATIENT AFTER EXITING SHEATH. IT WAS FURTHER REPORTED THAT THE SNARE WAS USED TO REMOVE THE DISLODGED COMPONENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206878 ↗
• MalfunctionOct 17, 2017Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A VASCULAR STENT PLACEMENT, THE BALLOON EXPANDABLE STENT ALLEGEDLY BECAME LODGED AS IT WAS BEING INTRODUCED INTO THE 6FR SHEATH. IT WAS FURTHER REPORTED THAT THE BALLOON EXPANDABLE STENT WAS REMOVED FROM THE SHEATH AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6956786 ↗
• MalfunctionSep 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED FROM THE BALLOON WHILE BEING INSERTED INTO THE 6FR INTRODUCER 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 6855219 ↗
• MalfunctionMay 12, 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 RETRACTING IT THROUGH THE SHEATH. REPORTEDLY, THE HEALTH CARE PROVIDER REMOVED THE BALLOON AND STENT OVER THE GUIDEWIRE FOR ANOTHER THAT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6565282 ↗
• MalfunctionSep 6, 2016Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT USING A CONTRALATERAL APPROACH THROUGH THE LEFT FEMORAL ARTERY FOR A STENOSIS, THE BALLOON EXPANDABLE STENT ALLEGEDLY DISLODGED FROM THE BALLOON CATHETER DELIVERY SYSTEM DURING RETRIEVAL TO REPOSITION THE STENT FOR DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE BALLOON ALLEGEDLY COULD NOT BE REMOVED WITH THE STENT; THEREFORE, THE BALLOON AND INTRODUCER SHEATH WERE ADVANCE INTO THE STENT, AND THE BALLOON WAS INFLATED TO PIN THE STENT AGAINST THE INSIDE WALL OF THE SHEATH TO REMOVE IT AS A SINGLE UNIT. REPORTEDLY, TRAUMA OCCURRED AT THE ACCESS SITE UPON REMOVAL OF THE SYSTEM REQUIRING MANUAL PRESSURE FOR HEMOSTASIS. THEREFORE, A SECOND ACCESS SITE WAS GAINED THROUGH THE RIGHT FEMORAL ARTERY, AND ANOTHER STENT WAS DEPLOYED. THE PATIENT WAS REPORTEDLY HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5930559 ↗