Bard Recalls LifeStent Solo Vascular Stents Due to Deployment Issues
Bard Peripheral Vascular is recalling specific lots of LifeStent Solo Vascular Stents due to a higher incidence of partial stent deployment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Bard Peripheral Vascular is recalling specific lots of the Bard LifeStent Solo Vascular Stent. The recall involves 4,112 units distributed nationwide in the United States. The affected product codes are EX062001CL, EX072001CL, EX062003CL, and EX072003CL.
The recall was initiated because the manufacturer determined there is a higher incidence rate of partial stent deployment associated with the use of these specific stents. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery and proximal popliteal artery.
Patients who have received these specific stents should contact their healthcare provider for further evaluation and guidance. The source text does not specify a particular action for consumers who have not yet received the device, but the recall is classified as Class I by the FDA.
The recalled product
- Product
- Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the…
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 4,112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Product Code:EX062001CL Lot Numbers: ANVG3284
- ANVH2474
- ANVJ1379
- ANVJ2590
- ANVK3364
- ANVL2910
- ANVG3862
- ANVH2475
- ANVJ2089
- ANVK3149
- ANVK3707
- ANVH0592
- ANVH3715
- ANVK3150
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Bard Peripheral Vascular Inc
See all →- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighCatheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
- HighDrainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
- ModerateVein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
- CriticalRotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12
Same hazard · partial deployment
See all →- HighMedtronic EverFlex Peripheral Stents Recalled for Partial Deployment Risk
FDA (Devices) · 2022-09-07
Similar recalls
- ModerateBard Lifestream Vascular Stent Recall Due to Sheath Compatibility Issues
FDA (Devices) · 2019-12-25
- ModerateBard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters
FDA (Devices) · 2014-01-29
- HighBard Hemodialysis Catheter Recalled Due to Tip Breakage During Placement
FDA (Devices) · 2019-09-04
- HighBoston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect
FDA (Devices) · 2018-02-28
- HighBard Biopsy EnCor Probe Recall for Sterility and Function Defects
FDA (Devices) · 2020-03-11
- SevereBard Equistream XK Hemodialysis Catheter Recalled for Tip Damage
FDA (Devices) · 2019-09-04