LifeStent XL Vascular & Biliary StentRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 6 models of LifeStent XL Vascular & Biliary Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2015 and Jun 8, 2026 — classified as 17 injuries, 48 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 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 LifeStent XL Vascular & Biliary Stent problems
Device problems
- Fracture18
- Break16
- Material Twisted/Bent14
- Material Deformation10
- Positioning Failure10
- Misfire9
- Detachment of Device or Device Component8
- Difficult to Remove7
Patient problems
- No Consequences Or Impact To Patient26
- No Clinical Signs, Symptoms or Conditions24
- No Known Impact Or Consequence To Patient8
- Foreign Body In Patient3
- Stenosis3
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Injury1
LifeStent XL Vascular & Biliary Stent models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeStent® XL Vascular & Biliary Stent EX061503CSSTENT, SUPERFICIAL FEMORAL ARTERY24 reports
- LifeStent® XL Vascular & Biliary Stent EX071503CSSTENT, SUPERFICIAL FEMORAL ARTERY18 reports
- LifeStent® XL Vascular & Biliary Stent EX061003CSCATHETER, BILIARY, DIAGNOSTIC11 reports
- LifeStent® XL Vascular & Biliary Stent EX071203CSSTENT, SUPERFICIAL FEMORAL ARTERY6 reports
- LifeStent® XL Vascular & Biliary Stent EX071003CSSTENT, SUPERFICIAL FEMORAL ARTERY4 reports
- LifeStent® XL Vascular & Biliary Stent EX061203CSSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
Recent LifeStent XL Vascular & Biliary Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Misfire
ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING LIFESTENT. IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND THEN ALLEGEDLY JUST STOPPED DEPLOYING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423667 ↗MalfunctionNov 18, 2025Break; Fracture; Misfire; Break; Fracture; Misfire
ON (B)(6) 2025.A 65-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT. DURING THE PROCEDURE, THE THUMB WHEEL AND PULL GRIP MALFUNCTIONED GOT PARTIAL DEPLOYMENT. FURTHER, THE PHYSICIAN NOTED THE STENT HOUSING MAY HAVE SHIFTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578825 ↗MalfunctionSep 2, 2025Break; Fracture; Difficult to Remove; Material Twisted/Bent; Break; Fracture; Difficult to Remove; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT WAS ALLEGEDLY FRACTURED AT POST-DELIVERY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 22931851 ↗MalfunctionSep 2, 2025Break; Fracture; Break; Fracture
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT WAS ALLEGEDLY FRACTURED OUTSIDE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 22931540 ↗MalfunctionAug 28, 2025Break; Positioning Failure; Break; Positioning Failure
ON (B)(6) 2025 A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. DURING THE INSTALLATION, THE LATCH ALLEGEDLY BROKE, AND THE STENT COULD NOT BE RELEASED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910906 ↗MalfunctionMay 26, 2025Break; Failure to Advance; Break; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION DUE TO EXTREME CALCIFICATION. UPON TRYING TO CROSS THE LESION THE DEPLOYMENT CATHETER BROKE. THE STENT AND DEPLOYMENT SYSTEM WERE ABLE TO BE REMOVED WITH NOTHING LEFT BEHIND. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083150 ↗MalfunctionMay 26, 2025Break; Fracture; Difficult to Remove; Misfire; Material Deformation; Break; Fracture; Difficult to Remove; Misfire; Material Deformation
ON (B)(6) 2025. A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT XL VASCULAR STENT. DURING THE PROCEDURE, THE SYSTEM WOULD NOT RELEASE THE STENT FULLY. THE DEVICE WAS REMOVED WITH A PARTIAL OF THE STENT AND THE OTHER PART DEPLOYED IN THE SFA. DOCTOR WOULD LIKE BOTH STENTS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083144 ↗MalfunctionSep 13, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY STENOSIS, THE STENT ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE PTA BALLOON WAS USED TO UNTWIST THE BALLOON. HOWEVER, ONCE THE BALLOON WAS DEFLATED, THE STENT ALLEGEDLY GOT TWISTED AGAIN. REPORTEDLY, THE TWISTED STENT WAS REMOVED AND THE PROCEDURE WAS NOT CONTINUED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215274 ↗InjuryJul 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT COMMON FEMORAL ARTERY, THE STENT WAS ALLEGEDLY TWISTED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED OCCLUSION. REPORTEDLY, THE PATIENT WAS TRANSFERRED TO A VASCULAR SURGEON TO TREAT THE REOCCLUDED SUPERFICIAL FEMORAL ARTERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Obstruction/Occlusion; Stenosis
MAUDE report 19771123 ↗MalfunctionJul 3, 2024Difficult or Delayed Positioning; Failure to Advance; Material Twisted/Bent; Difficult or Delayed Positioning; Failure to Advance; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, THE STENT STARTED TO DEPLOY FINE BUT MIDWAY THROUGH THE LESION, THE ROTATING WHEEL ALLEGEDLY DID NOT ROLLED OUT SMOOTHLY. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE TWISTED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19663631 ↗MalfunctionJun 14, 2024Break; Positioning Failure; Fracture; Self-Activation or Keying; Misfire; Break; Positioning Failure; Fracture; Self-Activation or Keying; Misfire
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL LESION, THE STENT ALLEGEDLY PARTIALLY DEPLOYED ABOUT TWO CENTIMETERS. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE FRACTURED AT THE TIP WHILE REMOVING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19535017 ↗MalfunctionFeb 20, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE LEFT FEMORAL ARTERY CROSSOVER APPROACH, THE STENT ALLEGEDLY FORESHORTENED TO HUNDRED MILLIMETERS OR SHORTER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738564 ↗MalfunctionOct 22, 2023Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY APPROACH, THE STENT ALLEGEDLY HAD A HARD STOP WHILE DEPLOYING; AND THE USER SWITCHED BACK TO THE THUMBWHEEL FOR FINAL DEPLOYMENT OF THE STENT. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER COULD NOT BE ADVANCED INTO THE SHEATH FOR POST DILATATION BECAUSE THE INNER CATHETER WAS ALLEGEDLY LEFT ON THE GUIDEWIRE. REPORTEDLY, THE SHEATH AND THE RETRACTING PART OF THE STENT CATHETER WERE REMOVED INTACT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17982348 ↗MalfunctionJun 23, 2023Misfire; Malposition of Device; Misfire; Malposition of Device
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DISTAL STENT TWO TO THREE CM OF THE STENT DEPLOYED AND THEN ALLEGEDLY BECAME STUCK. IT WAS FURTHER REPORTED THAT THE STENT GOT DEPLOYED AFTER USING SLIDE OPTION ON THE SIDE OF THE HANDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17189643 ↗MalfunctionJun 19, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING THE STENT PLACEMENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE STENT ALLEGEDLY APPEARED WRAPPED/TWISTED AFTER FINISHING DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE PHYSICIAN REWIRED THE STENT AND ATTEMPTED MULTIPLE BALLOON INFLATIONS BUT WAS UNSUCCESSFUL IN UN-KINKING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17151524 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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