Valeo Balloon Expandable Biliary StentRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 27 models of Valeo Balloon Expandable Biliary Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2015 and Apr 2, 2025 — classified as 7 injuries, 90 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (80 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Valeo Balloon Expandable Biliary Stent problems
Device problems
- Device Dislodged or Dislocated80
- Detachment of Device or Device Component19
- Difficult to Insert15
- Material Deformation10
- Device-Device Incompatibility4
- Retraction Problem4
- Failure to Advance3
- Migration3
Patient problems
- No Clinical Signs, Symptoms or Conditions52
- No Consequences Or Impact To Patient30
- No Patient Involvement8
- Stenosis3
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Edema1
- Foreign Body In Patient1
Valeo Balloon Expandable Biliary Stent models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Valeo® Balloon Expandable Biliary Stent EV08181CDCATHETER, BILIARY, DIAGNOSTIC9 reports
- Valeo® Balloon Expandable Biliary Stent EV08261CDCATHETER, BILIARY, DIAGNOSTIC8 reports
- Valeo® Balloon Expandable Biliary Stent EV08361CDCATHETER, BILIARY, DIAGNOSTIC7 reports
- Valeo® Balloon Expandable Biliary Stent EV08262CDCATHETER, BILIARY, DIAGNOSTIC6 reports
- Valeo® Balloon Expandable Biliary Stent EV08362CDCATHETER, BILIARY, DIAGNOSTIC6 reports
- Valeo® Balloon Expandable Biliary Stent EV08562CDCATHETER, BILIARY, DIAGNOSTIC6 reports
- Valeo® Balloon Expandable Biliary Stent EV07262CDCATHETER, BILIARY, DIAGNOSTIC5 reports
- Valeo® Balloon Expandable Biliary Stent EV07362CDCATHETER, BILIARY, DIAGNOSTIC5 reports
- Valeo® Balloon Expandable Biliary Stent EV08182CDCATHETER, BILIARY, DIAGNOSTIC5 reports
- Valeo® Balloon Expandable Biliary Stent EV08561CDCATHETER, BILIARY, DIAGNOSTIC5 reports
- Valeo® Balloon Expandable Biliary Stent EV06181CDCATHETER, BILIARY, DIAGNOSTIC4 reports
- Valeo® Balloon Expandable Biliary Stent EV07261CDCATHETER, BILIARY, DIAGNOSTIC4 reports
- Valeo® Balloon Expandable Biliary Stent EV06261CDCATHETER, BILIARY, DIAGNOSTIC3 reports
- Valeo® Balloon Expandable Biliary Stent EV07181CDCATHETER, BILIARY, DIAGNOSTIC3 reports
- Valeo® Balloon Expandable Biliary Stent EV07561CDCATHETER, BILIARY, DIAGNOSTIC3 reports
- Valeo® Balloon Expandable Biliary Stent EV10171CDCATHETER, BILIARY, DIAGNOSTIC3 reports
- Valeo® Balloon Expandable Biliary Stent EV06361CDCATHETER, BILIARY, DIAGNOSTIC2 reports
- Valeo® Balloon Expandable Biliary Stent EV07361CDCATHETER, BILIARY, DIAGNOSTIC2 reports
- Valeo® Balloon Expandable Biliary Stent EV07562CDCATHETER, BILIARY, DIAGNOSTIC2 reports
- Valeo® Balloon Expandable Biliary Stent EV10361CDCATHETER, BILIARY, DIAGNOSTIC2 reports
- Valeo® Balloon Expandable Biliary Stent EV06182CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV06262CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV06362CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV07182CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV09361CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV10261CDCATHETER, BILIARY, DIAGNOSTIC1 report
- Valeo® Balloon Expandable Biliary Stent EV10262CDCATHETER, BILIARY, DIAGNOSTIC1 report
Recent Valeo Balloon Expandable Biliary Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ILIAC VEIN, THE STENT WAS ALLEGEDLY DISLODGED FROM THE BALLOON WHEN TRIED TO POSITION IN THE TREATMENT AREA. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21749823 ↗MalfunctionSep 13, 2024Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT PASS THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20210025 ↗InjuryAug 7, 2024Contamination of Device Ingredient or Reagent; Detachment of Device or Device Component; Contamination of Device Ingredient or Reagent; Detachment of Device or Device Component
IT WAS REPORTED THAT SOMETIME POST A STENT PLACEMENT, A SMALL GRAY OR BLACK FOREIGN BODY WAS ALLEGEDLY FOUND WITHIN THE BLOOD CLOT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 19935286 ↗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 ↗MalfunctionApr 14, 2024Difficult to Insert; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE IN THE COMMON ILIAC ARTERY VIA THE CONTRALATERAL FEMORAL ACCESS, WHEN THE PHYSICIAN WAS GOING TO PASS THE STENT THROUGH THE SHEATH, THE STENT ALLEGEDLY DISLODGED AND CAME OFF THE BALLOON AT THE SHEATH VALVE. IT WAS FURTHER REPORTED THAT WHEN ATTEMPTED TO PUT THE STENT BACK THROUGH THE SHEATH, THE STENT ALLEGEDLY CRIMPED BETWEEN THE PHYSICIAN'S FINGER AND THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19103022 ↗MalfunctionApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY THROUGH THE LEFT COMMON FEMORAL ARTERY, THE STENT ALLEGEDLY PARTIALLY DISLODGED UPON ATTEMPTED DELIVERY. REPORTEDLY, THE STENT WAS REMOVED ALONG WITH THE STENT BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19017555 ↗MalfunctionMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY LOOSE ON THE SHAFT UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928359 ↗MalfunctionFeb 20, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO FIT THROUGH THE SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY GOT SLIPPED OFF AT THE HEMOVALVE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738585 ↗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 ↗MalfunctionJan 28, 2024Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE VIA THE RIGHT FEMORAL ARTERY, THE STENT ALLEGEDLY PUSHED BACK OFF THE BALLOON ON THE DELIVERY SHEATH. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY NOT ENTERED THROUGH THE VALVE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18593039 ↗MalfunctionJan 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERY, THE PACKAGING ALLEGEDLY CONTAINED DIFFERENT SIZED PRODUCT. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18577361 ↗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 ↗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 18463373 ↗MalfunctionNov 29, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FELL OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226000 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
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- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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