LifeStent Solo Vascular StentRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 4 models of LifeStent Solo Vascular Stent by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2015 and May 4, 2026 — classified as 17 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (46 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 Solo Vascular Stent problems
Device problems
- Positioning Failure46
- Break30
- Fracture25
- Material Deformation17
- Misfire15
- Failure to Advance14
- Premature Activation9
- Difficult to Advance6
Patient problems
- No Consequences Or Impact To Patient69
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient15
- Stenosis4
- No Patient Involvement3
- Occlusion3
- Calcium Deposits/Calcification2
- Claudication1
LifeStent Solo Vascular Stent models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LifeStent® Solo Vascular Stent EX062003CLSTENT, SUPERFICIAL FEMORAL ARTERY80 reports
- LifeStent® Solo Vascular Stent EX072003CLSTENT, SUPERFICIAL FEMORAL ARTERY18 reports
- LifeStent® Solo Vascular Stent EX062001CLSTENT, SUPERFICIAL FEMORAL ARTERY4 reports
- LifeStent® Solo Vascular Stent EX062002CLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
Recent LifeStent Solo Vascular Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Difficult to Remove; Misfire
ON (B)(6) 2026, A 65-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT. THE STENT BEGAN TO DEPLOY BUT MALFUNCTIONED AFTER APPROXIMATELY TWO CM HAD BEEN UNCOVERED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065646 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE BY USING LIFESTENT. IT WAS REPORTED THAT THE STENT ALLEGEDLY DETACHED FROM BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24529297 ↗MalfunctionFeb 25, 2026Failure to Advance; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING THE PROCEDURE, THE STENT FAILED TO ADVANCE PAST THE LESION. IT WAS FURTHER REPORTED THAT WHEN THE DELIVERY SYSTEM WAS INSERTED INTO THE ARTERY, THE PHYSICIAN FELT RESISTANCE AND SUBSEQUENTLY REMOVED THE SYSTEM. A DEFECT WAS OBSERVED ON THE SHAFT OF THE DELIVERY SYSTEM, WHICH APPEARED CRUMPLED ALONG THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440754 ↗MalfunctionFeb 13, 2026Break; Positioning Failure; Fracture; Detachment of Device or Device Component
ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A LIFESTENT DEVICE. DURING THE PROCEDURE IT WAS REPORTED THAT THE STENT DID NOT DEPLOY AND BECAME CAUGHT ON THE SHEATH. THE STENT WAS REMOVED FROM THE SHEATH AND TAKEN OUT OF THE PATIENT. THE DISTAL END OF THE STENT WAS FOUND TO BE BROKEN OFF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332341 ↗MalfunctionDec 22, 2025Material Frayed; Premature Activation; Difficult to Advance; Material Frayed; Premature Activation; Difficult to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO VASCULAR STENT. DURING THE PROCEDURE THE CATHETER DID NOT CROSS THE LESION EASILY. AFTER FINALLY CROSSING, IMAGING OF STENT DIDN¿T LOOK RIGHT. AFTER TAKING STENT OUT TO EXAMINE THEY NOTICED THE SHEATH OF STENT FRAYED AWAY FROM STENT. THERE IS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861614 ↗MalfunctionNov 6, 2025Activation Problem; Activation Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING LIFESTENT. PHYSICIAN DESCRIBED AS DEFECTIVE DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484854 ↗MalfunctionSep 17, 2025Break; Misfire; Material Deformation; Break; Misfire; Material Deformation
ON (B)(6) 2025 A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING DEPLOYMENT PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY, THE STENT PARTIALLY DEPLOYED AND ELONGATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23070431 ↗MalfunctionJul 25, 2025Break; Failure to Advance; Break; Failure to Advance
ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE LIFESTENT SOLO STENT. DURING THE PROCEDURE, THE STENT ALLEGEDLY FAILED TO ADVANCE INTO THE SHEATH BY THE SHEATH LOADING ONTO THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606092 ↗MalfunctionSep 4, 2024Break; Failure to Advance; Device-Device Incompatibility; Material Deformation; Break; Failure to Advance; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE IN LEFT SUPERIOR FEMORAL ARTERY, THE WIRE ALLEGEDLY CAME OUT OF THE LUMEN ABOVE THE DEPLOYMENT HANDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20137501 ↗MalfunctionAug 13, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT GROIN, THE STENT WAS ALLEGEDLY UNABLE TO BE ADVANCED OVER THE WIRE. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY HAD A KINK IN THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19978586 ↗InjuryJun 10, 2024Fracture; Fracture
IT WAS REPORTED THAT APPROXIMATELY TWELVE MONTHS POST A STENT PLACEMENT VIA "CONTRALATERAL" APPROACH, THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Stenosis
MAUDE report 19496732 ↗MalfunctionDec 11, 2023Break; Material Frayed; Failure to Advance; Difficult to Advance; Material Deformation; Material Twisted/Bent; Break; Material Frayed; Failure to Advance; Difficult to Advance; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT PRIOR TO A STENT PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY BENT OR FRAYED NEAR THE HANDLE DIRECTLY OUT OF THE PACKAGE. IT WAS FURTHER REPORTED THAT THE WIRE ALLEGEDLY HAD SOME RESISTANCE GOING THROUGH THE CATHETER AND WAS ALLEGEDLY FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18299305 ↗MalfunctionNov 30, 2023Failure to Advance; Material Deformation; Material Twisted/Bent; Failure to Advance; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT GO ON THE WIRE. IT WAS FURTHER REPORTED THAT THE STENT SHAFT WAS ALLEGEDLY TWISTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18236067 ↗MalfunctionDec 7, 2022Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15930349 ↗MalfunctionNov 10, 2022Fracture; Misfire; Detachment of Device or Device Component; Fracture; Misfire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY MISFIRED. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15769003 ↗
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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