Bard Recalls LifeStent Solo Vascular Stents Due to Deployment Issues

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 native

Manufacturer

Bard Peripheral Vascular Inc

Category

Medical Device — Vascular Stent

Hazard

• partial-deployment

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.

Distribution

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