Valeo® Balloon Expandable Biliary Stent EV07261CDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741000737), received between Jul 10, 2017 and Nov 14, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• InjuryNov 14, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY SIX MONTHS POST DEPLOYMENT OF A BALLOON EXPANDABLE STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, DUPLEX ULTRASOUND DEMONSTRATED IN-STENT RESTENOSIS IN THE TARGET LESION. APPROXIMATELY EIGHT MONTHS POST STENT DEPLOYMENT, DUPLEX ULTRASOUND DEMONSTRATED THE TARGET LESION WAS OCCLUDED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 8072370 ↗
• InjuryNov 14, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT APPROXIMATELY SIX MONTHS POST DEPLOYMENT OF A BALLOON EXPANDABLE STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, DUPLEX ULTRASOUND DEMONSTRATED IN-STENT RESTENOSIS IN THE TARGET LESION. APPROXIMATELY EIGHT MONTHS POST STENT DEPLOYMENT, DUPLEX ULTRASOUND DEMONSTRATED THE TARGET LESION WAS OCCLUDED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 8072366 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A BALLOON EXPANDABLE STENT IN THE RENAL ARTERY, IT WAS ALLEGED THAT THE STENT PREMATURELY DISLODGED FROM THE BALLOON BUT WAS ABLE TO BE DEPLOYED AT THE TREATMENT SITE. THE PROCEDURE WAS CONCLUDED, AND NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317462 ↗
• MalfunctionJul 10, 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 INTRODUCER SHEATH, RENDERING THE DEVICE UNUSABLE. IT WAS FURTHER REPORTED THAT ANOTHER BALLOON EXPANDABLE STENT WAS USED TO SUCCESSFULLY PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6699792 ↗